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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00000484
Other study ID # 3
Secondary ID
Status Completed
Phase Phase 3
First received October 27, 1999
Last updated November 25, 2013
Start date April 1966
Est. completion date January 1979

Study information

Verified date January 2000
Source National Heart, Lung, and Blood Institute (NHLBI)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.


Description:

BACKGROUND:

This grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and followed a cooperative study of the treatment of renal hypertension initiated in 1960 to evaluate the relative efficacy of several recognized drug regimens for reduction of blood pressure. Six centers (USPHS hospitals) and a coordinating center were involved in the trial.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Three hundred and eighty nine eligible patients were assigned to drug therapy consisting of chlorothiazide plus Rauwolfia serpentina or to placebo.

The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date January 1979
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 21 Years to 55 Years
Eligibility Men and women, ages 21-55. Mild essential hypertension (diastolic blood pressure over 90 mm Hg.

Study Design

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Prevention


Intervention

Drug:
chlorothiazide

Rauwolfia alkaloids


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

References & Publications (5)

Smith WM, Edlavitch SA, and Krushat WM: Prevention of Stroke in Mild Hypertension: Public Health Service Hospitals Trial. Perspectives in Cardiovascular Research, Vol. 4. Prophylactic Approach to Hypertensive Diseases, Yamori Y, Lovenberg W, and Freis ED, (Eds.), Raven Press, New York, l979, pp. 53-62.

Smith WM, Edlavitch SA, and Krushat WM: U.S. Public Health Service Hospitals Intervention Trial in Mild Hypertension. Hypertension, Determinants, Complications, and Intervention. Onesti G, and Klimt C, (Eds.), Grune & Stratton, New York, l979, pp. 38l-399.

Smith WM. Mild essential hypertension: benefit of treatment: discussion. Ann N Y Acad Sci. 1978 Mar 30;304:74-80. — View Citation

Smith WM: Hypertension--Effectiveness of Early Treatment in Preventing Sequellae. Proceedings of the Eisenhower Medical Center. Preventive Interventions in the Practice of Medicine, Spring, l979, pp. 8l-87.

U.S. Public Health Service Hospitals Cooperative Study Group. Smith WM, et al: Intervention Trial in Mild Hypertension. Epidemiology and Control of Hypertension. Paul, O (Ed.), Symposia Specialists, Miami, l975, pp. 46l-483.

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