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Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)
This study has been completed.
First Received: October 27, 1999   Last Updated: February 4, 2009   History of Changes
Sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Information provided by: National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier: NCT00000542
  Purpose

To determine if the combined incidence of nonfatal myocardial infarction and coronary heart disease death differs between diuretic-based and each of three alternative antihypertensive pharmacological treatments. Also, to determine, in a subset of this population, if lowering serum cholesterol with a HMG CoA reductase inhibitor in older adults reduces all-cause mortality compared to a control group receiving usual care. Conducted in conjunction with the Department of Veterans' Affairs.


Condition Intervention Phase
Cardiovascular Diseases
Coronary Disease
Diabetes Mellitus
Heart Diseases
Hypercholesterolemia
Hypertension
Myocardial Infarction
Myocardial Ischemia
Heart Failure
 Drug: Inhibitors, ACE
Drug: amlodipine
Drug: lisinopril
Drug: doxazosin
Drug: chlorthalidone
Drug: pravastatin
Behavioral: diet, fat-restricted
 Phase III

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention

Resource links provided by NLM:

Genetics Home Reference related topics: hypercholesterolemia
MedlinePlus related topics: Blood Pressure Medicines Cholesterol Coronary Artery Disease Diabetes Diets Heart Attack Heart Diseases Heart Failure High Blood Pressure
Drug Information available for: Doxazosin Doxazosin mesylate Pravastatin Pravastatin sodium Lisinopril Amlodipine Chlorthalidone Amlodipine besylate
U.S. FDA Resources

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: August 1993
Study Completion Date: March 2002
Primary Completion Date: March 2002 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Men and women hypertensive patients, ages 55 and above. A total of 36 percent were diabetics.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000542

Sponsors and Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Investigator: Barry Davis University of Texas
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:
Whelton PK, Williamson JD, Louis GT, Davis BR, Cutler JA. Experimental approaches to determining the choice of first-step therapy for patients with hypertension. The ALLHAT Research Group Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Clin Exp Hypertens. 1996 Apr-May;18(3-4):569-79. Review.
Elliott WJ. ALLHAT: the largest and most important clinical trial in hypertension ever done in the USA. Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial. Am J Hypertens. 1996 Apr;9(4 Pt 1):409-11. No abstract available.
Saunders E. Recruitment of African-American patients for clinical trials--the Allhat challenges. Antihypertensive and Lipid-lowering Trial to Prevent Heart Attack. J Natl Med Assoc. 1995 Aug;87(8 Suppl):627-9. No abstract available.
Manolio TA, Cutler JA, Furberg CD, Psaty BM, Whelton PK, Applegate WB. Trends in pharmacologic management of hypertension in the United States. Arch Intern Med. 1995 Apr 24;155(8):829-37. Review.
Davis BR, Cutler JA, Gordon DJ, Furberg CD, Wright JT Jr, Cushman WC, Grimm RH, LaRosa J, Whelton PK, Perry HM, Alderman MH, Ford CE, Oparil S, Francis C, Proschan M, Pressel S, Black HR, Hawkins CM. Rationale and design for the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). ALLHAT Research Group. Am J Hypertens. 1996 Apr;9(4 Pt 1):342-60.
Conlin PR, Williams GH. Use of calcium channel blockers in hypertension. Adv Intern Med. 1998;43:533-62. Review.
Anderson RJ, Alonso K. The ALLHAT challenges. J Natl Med Assoc. 1996 Jun;88(6):335, 368. No abstract available.
Messerli FH. What, if anything, is controversial about calcium antagonists? Am J Hypertens. 1996 Dec;9(12 Pt 2):177S-181S. Review.
Proschan M, Davis B, Cutler J, Ford C, Furberg C, Grimm R, Oparil S. ALLHAT and calcium channel blockers. ALLHAT Research Group. Am J Hypertens. 1997 Jan;10(1):142-3. No abstract available.
Cutler JA. Calcium-channel blockers for hypertension--uncertainty continues. N Engl J Med. 1998 Mar 5;338(10):679-81. No abstract available.
SoRelle R. National Heart, Lung, and Blood Institute halts part of antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT) Circulation. 2000 Mar 28;101(12):E9025. No abstract available.
Messerli FH. Implications of discontinuation of doxazosin arm of ALLHAT. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Lancet. 2000 Mar 11;355(9207):863-4. No abstract available.
[No authors listed] Major cardiovascular events in hypertensive patients randomized to doxazosin vs chlorthalidone: the antihypertensive and lipid-lowering treatment to prevent heart attack trial (ALLHAT). ALLHAT Collaborative Research Group. JAMA. 2000 Apr 19;283(15):1967-75. Erratum in: JAMA 2002 Dec 18;288(23):2976.
Lasagna L. Diuretics vs alpha-blockers for treatment of hypertension: lessons from ALLHAT. Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. JAMA. 2000 Apr 19;283(15):2013-4. No abstract available.
Pressel SL, Davis BR, Wright JT, Geraci TS, Kingry C, Ford CE, Piller LB, Bettencourt J, Kimmel B, Lusk C, Parks H, Simpson LM, Nwachuku C, Furberg CD. Operational aspects of terminating the doxazosin arm of The Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Control Clin Trials. 2001 Feb;22(1):29-41.
Grimm RH Jr, Margolis KL, Papademetriou V V, Cushman WC, Ford CE, Bettencourt J, Alderman MH, Basile JN, Black HR, DeQuattro V V, Eckfeldt J, Hawkins CM, Perry HM Jr, Proschan M. Baseline Characteristics of Participants in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Hypertension. 2001 Jan;37(1):19-27.
Barzilay JI, Jones CL, Davis BR, Basile JN, Goff DC Jr, Ciocon JO, Sweeney ME, Randall OS. Baseline characteristics of the diabetic participants in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Diabetes Care. 2001 Apr;24(4):654-8.
Wright JT Jr, Cushman WC, Davis BR, Barzilay J, Colon P, Egan D, Lucente T, Nwachuku C, Pressel S, Leenen FH, Frolkis J, Letterer R, Walsh S, Tobin JN, Deger GE. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT): clinical center recruitment experience. Control Clin Trials. 2001 Dec;22(6):659-73.
Pressel S, Davis BR, Louis GT, Whelton P, Adrogue H, Egan D, Farber M, Payne G, Probstfield J, Ward H. Participant recruitment in the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Control Clin Trials. 2001 Dec;22(6):674-86.
Cushman WC, Ford CE, Cutler JA, Margolis KL, Davis BR, Grimm RH, Black HR, Hamilton BP, Holland J, Nwachuku C, Papademetriou V, Probstfield J, Wright JT Jr, Alderman MH, Weiss RJ, Piller L, Bettencourt J, Walsh SM. Success and predictors of blood pressure control in diverse North American settings: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2002 Nov-Dec;4(6):393-405.
Piller LB, Davis BR, Cutler JA, Cushman WC, Wright JT Jr, Williamson JD, Leenen FH, Einhorn PT, Randall OS, Golden JS, Haywood LJ, . Validation of Heart Failure Events in the Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT) Participants Assigned to Doxazosin and Chlorthalidone. Curr Control Trials Cardiovasc Med. 2002 Nov 14 [epub ahead of print]
Pasternak RC. The ALLHAT Lipid Lowering Trial-Less Is Less. JAMA. 2002 Dec 18;288(23):3042-4. No abstract available.
Appel LJ. The verdict from ALLHAT--thiazide diuretics are the preferred initial therapy for hypertension. JAMA. 2002 Dec 18;288(23):3039-42. No abstract available.
[No authors listed] Major outcomes in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin vs usual care: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT-LLT). JAMA. 2002 Dec 18;288(23):2998-3007.
[No authors listed] Major outcomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic: The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). JAMA. 2002 Dec 18;288(23):2981-97.
Flack JM, Nasser SA. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Major outomes in high-risk hypertensive patients randomized to angiotensin-converting enzyme inhibitor or calcium channel blocker vs diuretic. Curr Hypertens Rep. 2003 Jun;5(3):189-191. No abstract available.
Papademetriou V, Piller LB, Ford CE, Gordon D, Hartney TJ, Geraci TS, Reisin E, Sumner BM, Wong ND, Nwachuku C, Narayan P, Haywood J, Habib G; ALLHAT Collaborative Research Group. Characteristics and lipid distribution of a large, high-risk, hypertensive population: the lipid-lowering component of the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). J Clin Hypertens (Greenwich). 2003 Nov-Dec; 5(6): 377-84.
Rahman M, Brown CD, Coresh J, Davis BR, Eckfeldt JH, Kopyt N, Levey AS, Nwachuku C, Pressel S, Reisin E, Walworth C; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. The prevalence of reduced glomerular filtration rate in older hypertensive patients and its association with cardiovascular disease: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Arch Intern Med. 2004 May 10;164(9):969-76.
Farag A, Bahtiyar G, Rothman J, McFarlane SI. The Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack (ALLHAT) Trial: Focus on the Diabetic Patient. Curr Hypertens Rep. 2004 Jun;6(3):212-4. No abstract available.
Barzilay JI, Davis BR, Bettencourt J, Margolis KL, Goff DC Jr, Black H, Habib G, Ellsworth A, Force RW, Wiegmann T, Ciocon JO, Basile JN; ALLHAT Collaborative Research Group. Cardiovascular outcomes using doxazosin vs. chlorthalidone for the treatment of hypertension in older adults with and without glucose disorders: a report from the ALLHAT study. J Clin Hypertens (Greenwich). 2004 Mar;6(3):116-25.
Davis BR, Furberg CD, Wright JT Jr, Cutler JA, Whelton P; ALLHAT Collaborative Research Group. ALLHAT: setting the record straight. Ann Intern Med. 2004 Jul 6;141(1):39-46.
Geraci TS, Geraci SA. What ALLHAT tells us about treating high-risk patients with hypertension and hyperlipidemia. J Cardiovasc Nurs. 2003 Nov-Dec;18(5):389-95. Review.
Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Diuretic versus alpha-blocker as first-step antihypertensive therapy: final results from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Hypertension. 2003 Sep;42(3):239-46. Epub 2003 Aug 18.
Davis BR, Cutler JA, Furberg CD, Wright JT, Farber MA, Felicetta JV, Stokes JD; ALLHAT Collaborative Research Group. Relationship of antihypertensive treatment regimens and change in blood pressure to risk for heart failure in hypertensive patients randomly assigned to doxazosin or chlorthalidone: further analyses from the Antihypertensive and Lipid-Lowering treatment to prevent Heart Attack Trial. Ann Intern Med. 2002 Sep 3;137(5 Part 1):313-20. Summary for patients in: Ann Intern Med. 2002 Sep 3;137(5 Part 1):I38.
Wright JT Jr, Dunn JK, Cutler JA, Davis BR, Cushman WC, Ford CE, Haywood LJ, Leenen FH, Margolis KL, Papademetriou V, Probstfield JL, Whelton PK, Habib GB; ALLHAT Collaborative Research Group. Outcomes in hypertensive black and nonblack patients treated with chlorthalidone, amlodipine, and lisinopril. JAMA. 2005 Apr 6;293(13):1595-608.
Rahman M, Pressel S, Davis BR, Nwachuku C, Wright JT Jr, Whelton PK, Barzilay J, Batuman V, Eckfeldt JH, Farber M, Henriquez M, Kopyt N, Louis GT, Saklayen M, Stanford C, Walworth C, Ward H, Wiegmann T. Renal outcomes in high-risk hypertensive patients treated with an angiotensin-converting enzyme inhibitor or a calcium channel blocker vs a diuretic: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2005 Apr 25;165(8):936-46.
Whelton PK, Barzilay J, Cushman WC, Davis BR, Iiamathi E, Kostis JB, Leenen FH, Louis GT, Margolis KL, Mathis DE, Moloo J, Nwachuku C, Panebianco D, Parish DC, Pressel S, Simmons DL, Thadani U; ALLHAT Collaborative Research Group. Clinical outcomes in antihypertensive treatment of type 2 diabetes, impaired fasting glucose concentration, and normoglycemia: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2005 Jun 27;165(12):1401-9.
Rahman M, Pressel S, Davis BR, Nwachuku C, Wright JT Jr, Whelton PK, Barzilay J, Batuman V, Eckfeldt JH, Farber MA, Franklin S, Henriquez M, Kopyt N, Louis GT, Saklayen M, Stanford C, Walworth C, Ward H, Wiegmann T; ALLHAT Collaborative Research Group. Cardiovascular outcomes in high-risk hypertensive patients stratified by baseline glomerular filtration rate. Ann Intern Med. 2006 Feb 7;144(3):172-80. Summary for patients in: Ann Intern Med. 2006 Feb 7;144(3):I33.

Additional publications automatically indexed to this study by National Clinical Trials Identifier (NCT ID):
Haywood LJ, Ford CE, Crow RS, Davis BR, Massie BM, Einhorn PT, Williard A; ALLHAT Collaborative Research Group. Atrial fibrillation at baseline and during follow-up in ALLHAT (Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial). J Am Coll Cardiol. 2009 Nov 24;54(22):2023-31.
Davis BR, Kostis JB, Simpson LM, Black HR, Cushman WC, Einhorn PT, Farber MA, Ford CE, Levy D, Massie BM, Nawaz S; ALLHAT Collaborative Research Group. Heart failure with preserved and reduced left ventricular ejection fraction in the antihypertensive and lipid-lowering treatment to prevent heart attack trial. Circulation. 2008 Nov 25;118(22):2259-67. Epub 2008 Nov 10.
Rahman M, Baimbridge C, Davis BR, Barzilay J, Basile JN, Henriquez MA, Huml A, Kopyt N, Louis GT, Pressel SL, Rosendorff C, Sastrasinh S, Stanford C; ALLHAT Collaborative Research Group. Progression of kidney disease in moderately hypercholesterolemic, hypertensive patients randomized to pravastatin versus usual care: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Am J Kidney Dis. 2008 Sep;52(3):412-24. Epub 2008 Aug 3.
Wright JT Jr, Harris-Haywood S, Pressel S, Barzilay J, Baimbridge C, Bareis CJ, Basile JN, Black HR, Dart R, Gupta AK, Hamilton BP, Einhorn PT, Haywood LJ, Jafri SZ, Louis GT, Whelton PK, Scott CL, Simmons DL, Stanford C, Davis BR. Clinical outcomes by race in hypertensive patients with and without the metabolic syndrome: Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Arch Intern Med. 2008 Jan 28;168(2):207-17.
Black HR, Davis B, Barzilay J, Nwachuku C, Baimbridge C, Marginean H, Wright JT Jr, Basile J, Wong ND, Whelton P, Dart RA, Thadani U; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Metabolic and clinical outcomes in nondiabetic individuals with the metabolic syndrome assigned to chlorthalidone, amlodipine, or lisinopril as initial treatment for hypertension: a report from the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial (ALLHAT). Diabetes Care. 2008 Feb;31(2):353-60. Epub 2007 Nov 13.
Margolis KL, Piller LB, Ford CE, Henriquez MA, Cushman WC, Einhorn PT, Colon PJ Sr, Vidt DG, Christian R, Wong ND, Wright JT Jr, Goff DC Jr; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Blood pressure control in Hispanics in the antihypertensive and lipid-lowering treatment to prevent heart attack trial. Hypertension. 2007 Nov;50(5):854-61. Epub 2007 Sep 10.
Davis BR, Piller LB, Cutler JA, Furberg C, Dunn K, Franklin S, Goff D, Leenen F, Mohiuddin S, Papademetriou V, Proschan M, Ellsworth A, Golden J, Colon P, Crow R; Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial Collaborative Research Group. Role of diuretics in the prevention of heart failure: the Antihypertensive and Lipid-Lowering Treatment to Prevent Heart Attack Trial. Circulation. 2006 May 9;113(18):2201-10. Epub 2006 May 1.

Study ID Numbers: 85
Study First Received: October 27, 1999
Last Updated: February 4, 2009
ClinicalTrials.gov Identifier: NCT00000542     History of Changes
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Diuretics
Physiological Effects of Drugs
Calcium Channel Blockers
Arteriosclerosis
Membrane Transport Modulators
Pravastatin
Pathologic Processes
Therapeutic Uses
Angiotensin-Converting Enzyme Inhibitors
Cardiovascular Diseases
Dyslipidemias
Arterial Occlusive Diseases
 Hyperlipidemias
Metabolic Diseases
Heart Diseases
Antilipemic Agents
Endocrine System Diseases
Ischemia
Adrenergic alpha-Antagonists
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Antihypertensive Agents
Doxazosin
Protease Inhibitors
Chlorthalidone
Natriuretic Agents
Adrenergic Antagonists
Infarction

ClinicalTrials.gov processed this record on March 18, 2010



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