Completed

Treatment of Hypertension

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What is being tested

chlorothiazide

+ Rauwolfia alkaloids
Drug
Who is being recruted

Cardiovascular Diseases
+1

+ Heart Diseases
+ Hypertension
From 21 to 55 Years
How is the trial designed

Prevention Study

Phase 3
Interventional
Study Start: April 1966

Summary

Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 26, 2013
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 1966Actual date on which the first participant was enrolled.

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

Official TitleTreatment of Hypertension 
Principal SponsorNational Heart, Lung, and Blood Institute (NHLBI)
Last updated: November 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
Prevention Study
Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

How participants are assigned to different groups/arms
In this clinical study, participants are placed into groups randomly, like flipping a coin. This ensures that the study is fair and unbiased, making the results more reliable. By assigning participants by chance, researchers can better compare treatments without external influences.

Other Ways to Assign Participants
Non-randomized allocation
: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

None (Single-arm trial)
: If the study has only one group, all participants receive the same treatment, and no allocation is needed.

How the interventions assigned to participants is kept confidential
Neither participants nor researchers know who is receiving which treatment. This is the most rigorous way to reduce bias, ensuring that expectations do not influence the results.

Other Ways to Mask Information
Open-label
: Everyone knows which treatment is being given.

Single-blind
: Participants do not know which treatment they are receiving, but researchers do.

Triple-blind
: Participants, researchers, and outcome assessors do not know which treatment is given.

Quadruple-blind
: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
From 21 to 55 YearsRange of ages for which participants are eligible to join.
Healthy volunteers not allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Cardiovascular Diseases
Heart Diseases
Hypertension
Vascular Diseases
Criteria

Men and women, ages 21-55. Mild essential hypertension (diastolic blood pressure over 90 mm Hg.



Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.
This study has no location dataSave this study to your profile to know when the location data is available. 

CompletedNo study centers