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Treatment of Hypertension

Primary Purpose

Cardiovascular Diseases, Heart Diseases, Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
chlorothiazide
Rauwolfia alkaloids
Sponsored by
National Heart, Lung, and Blood Institute (NHLBI)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cardiovascular Diseases

Eligibility Criteria

21 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 27, 1999
    Last Updated
    November 25, 2013
    Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00000484
    Brief Title
    Treatment of Hypertension
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2000
    Overall Recruitment Status
    Completed
    Study Start Date
    April 1966 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    January 1979 (Actual)

    3. Sponsor/Collaborators

    Name of the Sponsor
    National Heart, Lung, and Blood Institute (NHLBI)

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cardiovascular Diseases, Heart Diseases, Hypertension, Vascular Diseases

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Masking
    Double
    Allocation
    Randomized

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    chlorothiazide
    Intervention Type
    Drug
    Intervention Name(s)
    Rauwolfia alkaloids

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Men and women, ages 21-55. Mild essential hypertension (diastolic blood pressure over 90 mm Hg.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anthony Damato
    Organizational Affiliation
    USPHS Hospital
    First Name & Middle Initial & Last Name & Degree
    Richard Thurm
    Organizational Affiliation
    USPHS Hospital
    First Name & Middle Initial & Last Name & Degree
    Christfried Urner
    Organizational Affiliation
    USPHS Hospital
    First Name & Middle Initial & Last Name & Degree
    John Vaillancourt
    Organizational Affiliation
    USPHS Hospital
    First Name & Middle Initial & Last Name & Degree
    J. Warbasse
    Organizational Affiliation
    USPHS Hospital
    First Name & Middle Initial & Last Name & Degree
    Robert Wells
    Organizational Affiliation
    USPHS Hospital

    12. IPD Sharing Statement

    Citations:
    Citation
    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.
    Results Reference
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    PubMed Identifier
    360933
    Citation
    Smith WM. Mild essential hypertension: benefit of treatment: discussion. Ann N Y Acad Sci. 1978 Mar 30;304:74-80. doi: 10.1111/j.1749-6632.1978.tb25573.x. No abstract available.
    Results Reference
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    Citation
    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.
    Results Reference
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    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.
    Results Reference
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    Citation
    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.
    Results Reference
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    Treatment of Hypertension

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