Trial of antihypertensive interventions and management. Design, methods, and selected baseline results.
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.
Davis
B R
BR
University of Texas School of Public Health, Houston 77030.
Blaufox
M D
MD
Hawkins
C M
CM
Langford
H G
HG
Oberman
A
A
Swencionis
C
C
Wassertheil-Smoller
S
S
Wylie-Rosett
J
J
Zimbaldi
N
N
D000328:Adult; D000368:Aged; D000959:Antihypertensive Agents / Q000627:therapeutic use; D002986:Clinical Trials as Topic / Q000379:methods*; D003131:Combined Modality Therapy; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006973:Hypertension / Q000178:diet therapy* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D011897:Random Allocation; D012107:Research Design; D013223:Statistics as Topic
D000959:Antihypertensive Agents