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Biostatistics and Medical Informatics
Clinical Trials Program Statistical Data Analysis Center
Research Portfolio - Completed Trials and Publications

AMG 785 (2009-2012) This phase 2 clinical trial studied the safety and efficacy of AMG 785, an investigational bone building agent, in the treatment of postmenopausal women with low bone mineral density. Different doses and dosing frequencies of AMG 785 were compared to placebo in a double-blind fashion. The primary outcome was percent change from baseline in lumbar spine bone mineral density. Industry sponsored.

A8851009 (2007-2011) A phase 3 prospective, randomized trial comparing the efficacy of anidulafungin and voriconazole in combination to that of voriconazole alone when used for primary therapy of proven or probable invasive aspergillosis (IA). The primary endpoint was all cause mortality, measured 6 weeks after IA initiation of study drug subjects with proven or probable IA.

MGA031 (2006- 2011) A phase 2/3, randomized, double-blind, multicenter, multinational, 4-arm, controlled, dose-ranging study to evaluate efficacy and safety of MGA031, a humanized, FcR non-binding, anti-CD3 monoclonal antibody, in children and adults with recent-onset type 1 diabetes mellitus. Industry sponsored.

Sherry N, Hagopian W, Ludvigsson J, Jain SM, Wahlen J, Ferry Jr RJ, Bode B, Aronoff S, Holland C, Carlin D, King KL, Wilder RL, Pillemer S, Bonvini E, Johnson S, Stein KE, Koenig S, Herold KC, Daifotis AG, for the Protégé Trial Investigators. Teplizumab for treatment of type 1 diabetes (Protégé study):1-year results from a randomised, placebo-controlled trial. Lancet DOI:10.1016/S0140-6736(11)60931-8, 2011.

 

TREAT (2004-2010) Approximately 4000 patients from 700 sites in North America, Europe and Australia. A randomized, double-blind, multicenter study to assess the effect of anemia therapy with darbepoetin alfa on the composite event comprising all-cause mortality and cardiovascular (CV) events in subjects with both chronic kidney disease (CKD) and Type 2 diabetes mellitus (DM). Industry sponsored.

Mix TH, Brenner RM, Cooper ME, de Zeeuw D, Ivanovich P, Levey AS, McGill JB, McMurray JJ, Parfrey PS, Parving H-H, Pereira BJ, Remuzzi G, Singh AK, Solomon SD, Stehman-Breen C, Toto RD, Pfeffer MA. Rationale-Trial to Reduce Cardiovascular Events with Aranesp Therapy (TREAT): Evolving the management of cardiovascular risk in patients with chronic kidney disease. American Heart Journal 149 (3):408-13, 2005.

Pfeffer MA, Burdmann EA, Chen C-Y, Cooper ME, de Zeeuw D, Eckardt K-U, Feyzi JM, Ivanovich P, Kewalramani R, Levey AS, Lewis EF, McGill JB, McMurray JJ, Parfrey P, Parving H-H, Remuzzi G, Singh AK, Solomon SD, Toto R, for the TREAT Investigators. A trial of darbepoetin alfa in type 2 diabetes and chronic kidney disease. New England Journal of Medicine 361(21):2019-32, 2009.

 

PLATO (2006-2009) Approximately 18,000 patients with documented evidence of non-ST or ST segment elevation acute coronary syndrome (ACS). A randomized, double-blind, double-dummy, parallel group, international, multicenter study comparing the efficacy and safety of AZD6140 90mg twice daily with clopidogrel 75mg once daily in the prevention of fatal and nonfatal cardiovascular events in patients with non-ST or ST elevation ACS. Industry sponsored.

Wallentin L, Becker RC, Budaj A, Cannon CP, Emanuelsson H, Held C, Horrow J, Husted S, James S, Katus H, Mahaffey KW, Scirica BM, Skene A, Steg PG, Storey RF, Harrington RA, for the PLATO Investigators. Ticagrelor versus clopidogrel in patients with acute coronary syndromes. New England Journal of Medicine 361(11):1045-57, 2009.

 

CP-945,598 Obesity (2007-2009) A phase 3 clinical development program to evaluate the efficacy and safety of CP-945,598 in the treatment of obese subjects. The program was terminated on November 3, 2008 due to changing regulatory perspectives on the risk/benefit profile of the drug class and likely new regulatory requirements for approval. No safety issues were involved in the termination decision.

RWJ333369 (2006-2008) Approximately 600 patients with partial onset epilepsy and a history of inadequate response to treatment with at least one antiepileptic drug (AED).  A randomized, double-blind, placebo-controlled, dose-titration study to determine safety, tolerability and preliminary efficacy of RWJ-333369 as adjunctive therapy in subjects with treatment-resistant partial seizures or primarily generalized tonic-clonic seizures. Industry sponsored.

Sperling MR, Greenspan A, Cramer JA, Kwan P, Kälviäinen R, Halford JJ, Schmitt J, Yuen E, Cook T, Haas M, Novak, G. Carisbamate as adjunctive treatment of partial onset seizures in adults in two randomized, placebo-controlled trials. Epilespsai 51(3): 333-343, 2010.

 

CORONA (2004-2007) 5011 patients with chronic symptomatic systolic heart failure. Randomized, double-blind clinical trial in 20 countries. Comparison of rosuvastatin, along with all other medications prescribed, versus placebo. Combined primary endpoint was cardiovascular death or non-fatal MI or non-fatal stroke. Industry sponsored. Results presented at the November 2007 American Heart Association meeting.

Kjekshus J, Apetrei E, Barrios V, Böhm M, Cleland JGF, Cornel JH, Dunselman P, Fonseca C, Goudev A, Grande P, Gullestad L, Hjalmarson A, Hradec J, Jánosi A, Kamenský G, Komajda M, Korewicki J, Kuusi T, Mach F, Mareev V, McMurray JJV, Ranjith N, Schaufelberger M, Vanhaecke J, van Veldhuisen DJ, Waagstein F, Wedel H, Wikstrand J, for the CORONA Group. Rosuvastatin in older patients with systolic heart failure. New England Journal of Medicine 357(22):2248-61, 2007.

 

COX 2 INHIBITOR PROGRAM (2005-2007) This clinical development program for a dual-acting COX2 inhibitor was expected to include approximately 40,000 subjects in 36 phase 3 multicenter, randomized, placebo-and active comparator-controlled, studies in multiple indications including osteoarthritis, rheumatoid arthritis, chronic low back pain, neuropathic pain, visceral pain and acute pain. The program was terminated early due to insufficient efficacy in initial studies. Industry Sponsored.

ARIES (2004-2006) 393 patients with pulmonary arterial hypertension in two randomized double-blind clinical trials in 40 international sites. Comparison of ambrisentan, an endothelin A receptor antagonist, versus placebo. Primary endpoint was the change from baseline in the six-minute walk distance evaluated after 12 weeks of therapy. Industry sponsored.

Galié N, Olschewski H, Oudiz RJ, Torees F, Frost A, Ghofrani HA, Badesch DB, McGoon MD, McLaughlin VV, Roecker EB, Gerber MJ, Dufton C, Wiens BL, Rubin LJ, and for the Ambrisentanin Pulmonary Aterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy Studies (ARIES) Group. Amberisentan for the treatment of pulmonary arterial hypertension: Results of the Ambrisentanin Pulmonary Aterial Hypertension, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Efficacy (ARIES) Study 1 and 2. Circulation 117:3010-3019, 2008.

 

PAD20001 (2004 -2006) 283 patients without atherosclerotic disease with low HDLc from outpatient clinics in Europe. A multicenter, two staged, parallel, randomized, double- blind, placebo controlled study of the safety, tolerability and effects on plasma high density lipoprotein cholesterol of 12 weeks treatment with daily doses in subjects with low HDLc. Industry sponsored.

ADOPT (2000-2006) 4379 patients with recently diagnosed type 2 diabetes mellitus who are drug naive from North America and Europe at 471 centers. Randomized, double-blind clinical trial. Comparison of Avandia, rosiglitazone, monotherapy to metformin or glyburide/glibenclamide monotherapy. Primary outcome was monotherapy failure. Industry sponsored.

Kahn, SE, Haffner SM, Heise MA, Herman WH, Holman RR, Jones NP, Kravitz BG, Lachin JM, O'Neill C, Zinman B, Viberti G for the ADOPT Study Group. Glycemic durability of rosiglitazone, metformin, or glyburide monotherapy. New England Journal of Medicine 355(23):2427-53, 2006.

 

CSMS 802 & 804 (1999-2006) 890 patients with diabetic retinopathy in two trials in North America and Europe at 96 centers. Randomized, double-blind clinical trial. Comparison of Sandostatin LAR Depot, octreotide acetate for injectable suspension approved for long-term maintenance therapy in acromegalic patients, versus placebo. Primary outcome was progression of retinopathy. Industry sponsored.

PAA20001 (2004-2005) A multicenter, three staged, randomized, parallel group, double-blind, fenofibrate and placebo controlled dose-response evaluation of the safety, tolerability and effects on plasma high-density lipoprotein cholesterol and triglycerides of eight weeks treatment with daily doses in otherwise healthy subjects with low HDLc, mildly to moderately elevated triglycerides and normal low-density lipoprotein cholesterol. Study drug was a peroxisome proliferator-activated receptor (alpha) agonist. Industry sponsored.

DISPERSE2 (2004-2005) 926 patients from 200 sites in 14 countries. A double-blind, double-dummy, parallel group randomized dose confirmation and feasibility study of AZD6140 + Acetyl Salicylic Acid (ASA) compared with clopidogrel + ASA in patients with non-ST segment elevation acute coronary syndromes. Industry sponsored.

AGT (2003-2005) 416 patients with stable angina in United States at 100 centers. Randomized, double-blind, placebo controlled clinical trial to evaluate the efficacy and safety of Ad5FGF. Primary outcome was change from baseline in treadmill exercise duration at 12 weeks following treatment. Industry sponsored.

APC (2001-2005) 1950 patients with a history of colorectal adenomas. Randomized, double-blind, multicenter clinical trial. Comparison of two doses of celecoxib, a COX-2 inhibitor, versus placebo. Primary outcome was the occurence of new adenomatous polyps. NCI and industry sponsored. Results presented at April 2006 American Association for Cancer Research Annual Meeting.

VERITAS (2003-2004) Approximately 1391 patients with acute heart failure in two randomized double-blind clinical trials in 15 international sites. Comparison of tezosentan, an endothelin receptor antagonist, versus placebo. Primary endpoint was the incidence of death or worsening heart failure at 7 days following study drug initiation.

Bertagnolli MM, Eagle CJ, Zauber AG, Redston M, Solomon SD, Kim K, Tang J, Rosenstein RB, Wittes J, Corle D, Hess TM, Woloj GM, Boisserie F, Anderson, WF, Viner JL, Bagheri D, Burn J, Chung DC, Dewar T, Foley TR, Hoffman N, Macrae F, Pruitt RE, Saltzman JR, Salzberg B, Sylwestrowicz T, Gordon GB, Hawk ET for the APC Study Investigators. Celecoxib for the prevention of sporadic colorectal adenomas. New England Journal of Medicine 355(9):873-84, 2006.

 

ESSENTIAL (2001-2004) 1852 patients with advanced heart failure in two trials. Randomized, double-blind, multicenter clinical trial.Comparison of Enoximone, a type -3 phosphodieterase inhibitor, versus placebo. Primary outcome was all cause mortality or cardiovascular hospitalization. Industry sponsored.

SPORTIF 3 and V (2000-2004) 7332 patients with atrial fibrillation in two trials (3922 from USA and Canada in double-blind trial; 3410 from 25 other countries in open label trial). Randomized clinical trial. Comparison of Exanta, an oral direct thrombin inhibitor, versus dose-adjusted warfarin. Primary outcome was stroke and systemic embolic events. Industry sponsored. Results from SPORTIF 3 were presented at April 2003 American College of Cardiology Late-Breaking Trials.

Executive Steering Committee on behalf of the SPORTIF 3 Investigators. Stroke prevention with the oral direct thrombin inhibitor ximelagatran compared with warfarin in patients with non-valvular atrial fibrillation (SPORTIF 3): randomized controlled trial. The Lancet 362: 1691-98, 2003.

Executive Steering Committee for the SPORTIF 5 Investigators. Ximelagatran vs warfarin for stroke prevention in patients with nonvalvular atrial fibrillation; a randomized trial. Journal of the American Medical Association 293:690-98, 2005.

 

DFMO in Bladder Cancer (1999-2004) Approximately 194 patients with low grade superficial bladder cancer. Randomized, multicenter double-blind clinical trial. Comparison of DFMO, a chemopreventive agent, versus placebo in addition to standard care following surgical resection of tumor. Primary outcome was disease recurrence. Jointly sponsored by NCI and industry.

DFMO in Skin Cancer (1998-2004) 291 patients with a prior history of skin cancer at University of Wisconsin Comprehensive Cancer Center (UWCCC). Randomized double-blind clinical trial. Comparison of DFMO, a chemopreventive agent, versus placebo. Primary outcome was rate of new skin cancer development. NCI sponsored.

COMPANION (1999-2002) 1520 patients with congestive heart failure. Randomized clinical trial. Comparison of optimal drug treatment versus optimal drug treatment with biventricular pacing versus optimal drug treatment with biventricular pacing and defibrillation. Primary endpoint was all-cause mortality/all-cause hospitalization. Results presented at March 2003 American College of Cardiology Late-Breaking Trials and September 2003 Heart Failure Society of America Late-Breaking Trials.

Bristow MR, Saxon LA, Boehmer J, Krueger S, Kass DA, De Marco T, Carson P, DiCarlo L, DeMets D, White BG, DeVries DW, and Feldman AM. Cardiac-Resynchronization Therapy with or without and Implantable Defibrillator in Advanced Chronic Heart Failure. The New England Journal of Medicine 350: 2140-50, 2004.

Carson P, Anand I, O'Connor C, Jaski B, Steinber J, Lwin A, Lindenfeld J. Ghali J, Barnet J, Feldman AM, Bristow MR. Mode of Death in Advanced Heart Failure: the Comparison of Medical, Pacing, and Defibrillation Therapies in Heart Failure, Journal of the American College of Cardiology 46, No. 12: 2329-34, 2005.

 

ENABLE (1999-2001) 1613 patients with advanced chronic heart failure in two trials (800 from North America and 800 from Europe, Australia and Israel). Randomized, double-blind clinical trial. Comparison of Bosentan, an endothelin antagonist, to placebo. Primary endpoints were (1) all-cause mortality/hospitalization for heart failure and (2) clinical status at nine months. Industry sponsored. Results presented at March 2002 American College of Cardiology Late-Breaking Trials.

VIETNAM TAMOXIFEN STUDY (1993-2001) 709 premenopausal women patients with operable breast cancer from Vietnam and China. Randomized clinical trial. Comparison of oophorectomy and tamoxifen adjuvant therapy to observation. Primary outcomes were overall survival and recurrence free survival. Supported by grants from the US NIH CA 64339, University of Wisconsin Clinical Cancer Center, and by the International Breast Cancer Research foundation, Madison, Wisconsin, USA.

Love RR, Duc NB, Allred DC, Binh NC, Dinh NV, Kha NN, Thuan TV, Mohsin SK, Roanh leD, Khang HX, Tran TL, Quy TT, Thuy NV, The PN, Cau TT, Tung ND, Huong DT, Quang leM, Hien NN, Thuong L, Shen TZ, Xin Y, Xhang Q, Havighurst TC, Yang YF, Hillner BE, DeMets, DL. Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancer. Journal of Clinical Oncology 20:2559-2566, 2002.

Love RR, Nguyen BD, Havighurst TC, Mohsin SK, Zhang Q, DeMets DL, Allred DC. HER-2/neu Overexpression and Response to Oophorectomy Plus Tamoxifen Adjuvant Therapy in Estrogen Receptor-Positive Premenopausal Women with Operable Breast Cancer. Journal of Clinical Oncology 21:453-457, 2003.

 

COPERNICUS (1997-2000) 2289 patients with severe congestive heart failure (Class 4) and ejection fraction less than 25 percent from North and South America, Europe, Australia, and Asia in 334 centers. Randomized, double-blind clinical trial. Comparison of Carvedilol, a beta blocker, versus placebo. Primary endpoint was all-cause mortality. Industry sponsored. Results presented at August 2000 European College of Cardiology Meeting, November 2000 American Heart Association Meeting, and March 2001 American College of Cardiology Meeting.

Rouleau, J.L., Roecker, E.B., Tendera, M., Mohacsi, P., Krum, H., Katus, H.A., Fowler, M.B., Coats, A.J.S. and Packer, M. Influence of pretreatment systolic blood pressure on the effects of carvedilol in patients with severe chronic heart failure: The COPERNICUS study, Journal of the American College of Cardiology 43:1423-1429, 2004.

Krum, H., Mohacsi, P., Katus, H.A., Tendera, M., Rouleau, J.L., Fowler, M.B., Coats, A.J., Roecker, E.B. and Packer, M. Are beta-blockers needed in patients receiving spironolactone for severe chronic heart failure? An analysis of the COPERNICUS study, American Heart Journal, in press.

Packer M, Coats A, Fowler M, Katus H, Krum H, Mohacsi P, Rouleau J, Tendera M, Castaigne A, Roecker E, Schultz M, and DeMets D, for the Carvedilol Prospective Randomized Cumulative Survival Study Group. Effect of Carvedilol on Survival in Severe Chronic Heart Failure. New England Journal of Medicine 344:1651-1658, 2001.

Packer M, Fowler MB, Roecker EB, Coats AJS, Katus HA, Krum H, Mohacsi P, Rouleau JL, Tendera M, Staiger C, Holcslaw TL, Amann-Zalan I, DeMets DL: Effect of carvedilol on the morbidity of patients with severe chronic heart failure. Circulation 106:2194-2199, 2002.

Krum H, Roecker EB, Mohacsi P, Rouleau JL, Tendera M, Coats AJS, Katus HA, Fowler MB, Packer M: Effects of initiating carvedilol in patients with severe chronic heart failure. Journal of the American Medical Association 289:712-718, 2003.

 

PRAISE 2 (1996-2000) 1652 patients with severe heart failure (Class 3b and 4) of non-ischemic etiology. Randomized double-blind clinical trial. Comparison of Amlodipine, a calcium channel blocker, to placebo. Primary outcomes were all-cause mortality, cardiovascular mortality, and health care resource utilization. Industry sponsored. Results presented at March 2000 American College of Cardiology Meeting.

EXCITE (1997-1999) 7232 patients undergoing PTCA or stent placement from the Americas, Europe, Australia, New Zealand, Israel, and South Africa in 412 centers. Randomized double-blind trial. Comparison of Xemilofiban, an oral anti-platelet agent, versus placebo. Primary outcome was occurrence of death, MI, or urgent revascularization at 6 months. Industry sponsored. Results presented at March 1999 American College of Cardiology Meeting.

O'Neil W, Serruys P, Knudtson M, van Es G, van der Zwaan C, Kleiman J, Gong J, Roecker E, Dreiling R, Alexander J, Anders R, for the EXCITE Trial Investigators. A Prospective Randomized Double-Blind Clinical Trial of Long-Term Oral Platelet Glycoprotein Receptor Blockade After Percutaneous Coronary Intervention. New England Journal of Medicine (342):1316-24, 2000.

 

MERIT (1997-1999) 3991 patients with severe heart failure (Class 4) in Europe and North America at 313 centers. Randomized, double-blind clinical trial. Comparison of Metoprolol, a beta-blocker, versus placebo. Primary outcome was mortality with composite of all-cause mortality and all-cause hospitalization as a secondary endpoint. Industry sponsored. Results presented at March 1999 American College of Cardiology Meeting and at August 1999 European College of Cardiology Meeting.

MERIT-HF Study Group. Effect of Metoprolol CR/XL in Chronic Heart Failure: Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure. Lancet 353:2001-2007, 1999.

Hjalmarson A, Goldstein S, Fagerberg B, et al, for the MERIT-HF Study Group. Effects of Controlled-Release Metoprolol on Total Mortality, Hospitalizations, and Well-being in Patient with Heart Failure, The Metoprolol CR/XL Randomised Intervention Trial in Congestive Heart Failure (MERIT-HF). Journal of the American Medical Association 10:1295-1336, 2000.

 

REACH (1997-1998) 370 patient with heart failure randomized to either of two doses of Bosentan, an endothelin antagonist, or placebo. Primary endpoint was change in clinical status. Industry sponsored. Results presented at 1998 American Heart Association Meeting.

THS 95.1 (1997-1998) 850 trauma patients with persistent hypoperfusion despite pre-hospital therapy admitted to trauma center in the United States. Goal was 35-40 centers. Randomized clinical trial. Comparison of DCLHB, a purified human hemoglobin solution, versus saline. Primary outcome was 28 day mortality. Industry sponsored with special IND approved. First study conducted under DHHS Waiver of Informed Consent Requirements in Certain Emergency Research.

Sloan EP, Koenigsberg M, Gens D, Cipolle M, Runge J, Mallory MN, Rodman G, for the DCLHb Traumatic Hemorrhagic Shock Study Group. Diaspirin Cross-Linked Hemoglobin (DCLHb) in the Treatment of Severe Traumatic Hemorrhagic Shock: A Randomized Controlled Efficacy Trial. Journal of the American Medical Association 282:1857-1864, 1999.

Lewis RJ, Berry DA, Cryer H, Fost N, Krome R, Washington GR, Houghton J, Blue JW, Bechhofer R, Cook T, and Fisher M. Monitoring a Clinical Trial Conducted Under the Food and Drug Administration Regulations Allowing a Waiver of Prospective Informed Consent: The Diaspirin Cross-Linked Hemoglobin Traumatic Hemorrhagic Shock Efficacy Trial. Annals of Emergency Medicine 38:397-404, 2001.

 

AB-02 (1995-1998) Approximately 270 patients with depressed ventricular function undergoing coronary artery bypass graft surgery . Randomized, double-blind clinical trial. Comparison of Adenosin, an additive to cardioplegic solutions, versus placebo. Primary outcome was the amount of 1) dopamine and 2) inotropic support used during the first seven postoperative days. Industry sponsored.

VEST (1994-1998) 3833 patients with severe left ventricular heart failure (Class 3 and 4) from the United States and Canada in 189 centers. Randomized double-blind clinical trial. Comparison of Vesnarinone, an ionotropic drug, versus placebo. Primary outcome was mortality and cardiovascular morbidity. Industry sponsored and coordinated through an academic network. Results presented at November 1996 American Heart Association Meeting and at March 1997 American College of Cardiology Meeting.

Cohn J, Goldstein S, Greenberg B, Lorell B, Bourge R, Jaski B, Gottlieb S, McGrew F, DeMets D, and White B, for the VESNARINONE Trial Investigators. A dose-dependent increase in mortality with vesnarinone among patients with severe heart failure. New England Journal of Medicine 339:1810-1816, 1998.

 

CARS (1993-1997) 8803 patients enrolled 3 to 21 days after the occurrence of a myocardial infarction from North America at 293 centers. Randomized, double-blind clinical trial. Comparison of Coumadin, warfarin, in two fixed doses with aspirin versus aspirin alone. Primary outcome was occurrence of clinical events. Industry sponsored. Results presented at March 1996 and March 1997 American College of Cardiology Meeting and at November 1997 American Heart Association Meeting.

Coumadin Aspirin Reinfarction Study (CARS) Investigators. Randomized Double-Blind Trial of Fixed Low Dose Warfarin with Aspirin After Myocardial Infarction. Lancet 350 (9075): 389-396, 1997.

 

ACTS (1992-1995) 730 patients with amyotrophic lateral sclerosis in North America at 36 centers. Randomized, double-blind clinical trial. Comparison of rHCNTF, a neurotrophic growth factor, in two doses versus placebo. Primary outcome was rate of change from baseline in isometric muscle strength to nine months. Industry sponsored. SDAC served as the data management center as well as the analysis center. Results presented at May 1995 American Academy of Neurology Meeting.

ALS CNTF Treatment Study Group. A Double-Blind Placebo-Controlled Clinical Trial of Subcutaneous Recombinant Human Ciliary Neurotrophic Factor (rHCNTF) in Amyotrophic Lateral Sclerosis. Neurology 46:1244-1249, 1996.

 

PRAISE (1992-1994) 1153 patients with severe heart failure (Class 3b and 4) and ejection fractions less than 30 percent in United States at 105 sites. Randomized, double-blind clinical trial. Comparison of Amlodipine, a calcium channel blocker, versus placebo. Primary outcomes were all-cause mortality and hospitalization for major cardiovascular events. Industry sponsored.

Packer M, O'Connor C, Ghali J, Pressler M, Carson P, Belkin R, Miller A, Neuberg G, Frid D, Werthheimer J, Cropp A, and DeMets D, for the Prospective Randomized Amlopidine Survival Evaluation Study Group. Effect of Amlodipine on Morbidity and Mortality in Severe Chronic Heart Failure. New England Journal of Medicine 335:1107-1113, 1996.

 

PROMISE (1989-1990) 1088 patients with severe chronic heart failure (Class 3 and 4) from the United States and Canada at 119 centers. Randomized, double-blind clinical trial. Comparison of Milrinone, a phosphodiesterase inhibitor, versus placebo. Primary outcome was all-cause mortality. Industry sponsored.

Packer M, Carver J, Rodeheffer R, Ivanhoe R, DiBianco R, Zeldis S, Hendrix G, Bommer W, Elkayam U, Kukin M, Mallis G, Sollano J, Shannon J, Tandon P, and DeMets D, for the PROMISE Study Research Group. Effect of Oral Milrinone on Mortality in Severe Chronic Heart Failure. New England Journal of Medicine 325:1468-1475, 1991.

 

Wisconsin Tamoxifen Study (1986-1988) 145 post-menopausal women under the age of 65 with node negative breast cancer. Randomized double-blind clinical trial. Comparison of Tamoxifen versus placebo. Primary outcomes were toxicity, bone density, and lipid and lipoprotein changes. Sponsored by American Cancer Society and industry.

Love RR, Mazess RB, Tormey DC, Barden HS, Newcomb PA, Jordan VC. Bone mineral density in women with breast cancer treated with adjuvant tamoxifen for at least two years. Breast Cancer Research and Treatment 12:297-301, 1988.

Love RR, Wiebe DA, Newcomb PA, Cameron L, Leventhal H, Jordan VC, Feyzi J, DeMets DL. Effects of tamoxifen on cardiovascular risk factors in postmenopausal women. Annals of Internal Medicine 115:860-864, 1991.

 
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