Trial of antihypertensive interventions and management. Design, methods, and selected baseline results

Barry R. Davis, M. Donald Blaufox, C. Morton Hawkins, Herbert G. Langford, Albert Oberman, Charles Swencionis, Sylvia Wassertheil-Smoller, Judy Wylie-Rosett, Neal Zimbaldi

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31 Scopus citations

Abstract

The Trial of Antihypertensive Interventions and Management was a multicenter randomized, placebo-controlled trial designed to assess the effectiveness of various combinations of pharmacologic and dietary interventions in the treatment of mild hypertension (diastolic blood pressure 90-100 mmHg). The primary outcome was blood pressure change between baseline and 6 months. The study consisted of a 3 × 3 factorial design wherein participants were randomly allocated to nine drug-diet treatment groups. Drugs included placebo, diuretic, and beta-blocker. Diets were usual, weight loss, and low sodium/high potassium. The basic strategy was to address clinical questions of interest by comparing mean blood pressure changes of selected drug-diet combinations. This paper describes the study including experimental design, sample size considerations, statistical analysis, organizational structure, and baseline findings.

Original languageEnglish (US)
Pages (from-to)11-30
Number of pages20
JournalControlled Clinical Trials
Volume10
Issue number1
DOIs
StatePublished - Mar 1989

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Keywords

  • Clinical trial design
  • hypertension
  • multiple comparisons

ASJC Scopus subject areas

  • Pharmacology

Cite this

R. Davis, B., Blaufox, M. D., Hawkins, C. M., Langford, H. G., Oberman, A., Swencionis, C., Wassertheil-Smoller, S., Wylie-Rosett, J., & Zimbaldi, N. (1989). Trial of antihypertensive interventions and management. Design, methods, and selected baseline results. Controlled Clinical Trials, 10(1), 11-30. https://doi.org/10.1016/0197-2456(89)90016-0