How FDA currently makes decisions on clinical studies

Clinical Trials

Volumn 2, Issue 4, 2005, Pages 276-281

  Temple, Robert ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

AMLODIPINE; ANGIOTENSIN RECEPTOR ANTAGONIST; CARVEDILOL; CIMETIDINE; DIPEPTIDYL CARBOXYPEPTIDASE INHIBITOR; IRBESARTAN; LOSARTAN; PLACEBO; VALSARTAN;

BAYES THEOREM; BIOEQUIVALENCE; CLINICAL TRIAL; CONFERENCE PAPER; CONGESTIVE HEART FAILURE; DECISION MAKING; DIABETIC NEPHROPATHY; DOSE RESPONSE; DRUG APPROVAL; DRUG BLOOD LEVEL; DRUG EFFECT; DUODENUM CANCER; FOOD AND DRUG ADMINISTRATION; HEALTH CARE POLICY; HEART FAILURE; HEART LEFT VENTRICLE FAILURE; HUMAN; PRIORITY JOURNAL;

ADULT; ANGIOTENSIN-CONVERTING ENZYME INHIBITORS; ANTIHYPERTENSIVE AGENTS; CARBAZOLES; CHILD; CLINICAL TRIALS; DIABETIC NEPHROPATHIES; EVIDENCE-BASED MEDICINE; HEART FAILURE, CONGESTIVE; HUMANS; PROPANOLAMINES; TETRAZOLES; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION; VALINE;

EID: 24944505163     PISSN: 17407745     EISSN: 17407753     Source Type: Journal    
DOI: 10.1191/1740774505cn097oa     Document Type: Conference Paper

References (6)

1. The CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med 1987; 316: 1429-35.
2. Lewis EJ, Hunsicker LG, Clarke WR et al. Renoprotective effect of the angiotensin-receptor antagonist irbesartan in patients with nephropathy due to type 2 diabetes. N Engl J Med 2001; 345: 851-60.
3. Brenner BM, Cooper ME, de Zeeuw D et al. Effects of losartan on renal and cardiovascular outcomes in patients with type 2 diabetes and nephropathy. N Engl J Med 2001; 345: 861-69.
4. Dargie HJ. Effect of carvedilol on outcome after myocardial infarction in patients with left-ventricular dysfunction: the CAPRICORN randomised trial. Lancet 2001; 357: 1385-90.
5. Packer M, Coats AJ, Fowler MB et al. Effect of carvedilol on survival in severe chronic heart failure. N Engl J Med 2001; 344: 1651-58.
6. Conn JN, Togoni G, Valsartan Heart Failure Trial Investigators. A randomized trial of the angiotensin-receptor blocker valsartan in chronic heart failure. N Engl J Med 2001; 345: 1667-75.