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Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives (HOS)

Primary Purpose

Obesity, Hypertension

Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
sibutramine
sibutramine
verapamil/trandolapril
metoprolol/HCT
felodipine/ramipril
Sponsored by
Abbott
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Treated essential hypertension.
  • Obesity: BMI 27-35 kg/m2

Exclusion Criteria:

  • Secondary hypertension.
  • Stage 3 hypertension.
  • Secondary obesity; BMI > 35kg/m2.
  • CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis.
  • Kidney failure.
  • Liver failure.
  • Hyperthyroidism.
  • Unstable DM.
  • Carcinoma.
  • Severe chronic infectious disease.
  • Alcohol or drug abuse.
  • Pregnancy.
  • Epilepsy.
  • Psychosis or treatment with antidepressants or major tranquilizers

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    1

    2

    3

    Arm Description

    verapamil/trandolapril

    metoprolol/HCT

    felodipine/ramipril

    Outcomes

    Primary Outcome Measures

    Systolic Blood Pressure
    Diastolic Blood Pressure

    Secondary Outcome Measures

    Full Information

    First Posted
    March 26, 2008
    Last Updated
    May 16, 2008
    Sponsor
    Abbott
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00679653
    Brief Title
    Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
    Acronym
    HOS
    Official Title
    Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2002 (undefined)
    Primary Completion Date
    December 2003 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Abbott

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    To study the effect of sibutramine treatment on weight reduction and blood pressure improvement in three groups with antihypertensive therapy whose blood pressure was not adequately controlled with antihypertensive combination treatment.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Obesity, Hypertension

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    171 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Active Comparator
    Arm Description
    verapamil/trandolapril
    Arm Title
    2
    Arm Type
    Active Comparator
    Arm Description
    metoprolol/HCT
    Arm Title
    3
    Arm Type
    Active Comparator
    Arm Description
    felodipine/ramipril
    Intervention Type
    Drug
    Intervention Name(s)
    sibutramine
    Other Intervention Name(s)
    ABT-991, Meridia, Reductil
    Intervention Description
    8-wks, sibutramine, 10 mg, capsules, once daily
    Intervention Type
    Drug
    Intervention Name(s)
    sibutramine
    Other Intervention Name(s)
    ABT-991, Meridia, Reductil
    Intervention Description
    8-wks, sibutramine, 15 mg, capsules, once daily
    Intervention Type
    Drug
    Intervention Name(s)
    verapamil/trandolapril
    Intervention Description
    2 wk Run-in phase, antihypertensive therapy only
    Intervention Type
    Drug
    Intervention Name(s)
    metoprolol/HCT
    Intervention Description
    2 wk Run-in phase, antihypertensive therapy only
    Intervention Type
    Drug
    Intervention Name(s)
    felodipine/ramipril
    Intervention Description
    2 wk Run-in phase, antihypertensive therapy only
    Primary Outcome Measure Information:
    Title
    Systolic Blood Pressure
    Time Frame
    Duration of Study
    Title
    Diastolic Blood Pressure
    Time Frame
    Duration of Study

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Treated essential hypertension. Obesity: BMI 27-35 kg/m2 Exclusion Criteria: Secondary hypertension. Stage 3 hypertension. Secondary obesity; BMI > 35kg/m2. CAD; MI within past 6 months; NYHA stage 3 or 4 heart failure; tachyarrhythmia/atrial fibrillation; myocarditis. Kidney failure. Liver failure. Hyperthyroidism. Unstable DM. Carcinoma. Severe chronic infectious disease. Alcohol or drug abuse. Pregnancy. Epilepsy. Psychosis or treatment with antidepressants or major tranquilizers

    12. IPD Sharing Statement

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    Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives

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