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

Control Clin Trials. 1989 Mar;10(1):11-30. doi: 10.1016/0197-2456(89)90016-0.

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 X 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.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Adult
  • Aged
  • Antihypertensive Agents / therapeutic use
  • Clinical Trials as Topic / methods*
  • Combined Modality Therapy
  • Double-Blind Method
  • Female
  • Humans
  • Hypertension / diet therapy*
  • Hypertension / drug therapy*
  • Male
  • Middle Aged
  • Multicenter Studies as Topic
  • Random Allocation
  • Research Design*
  • Statistics as Topic

Substances

  • Antihypertensive Agents