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

This study has been completed.
Sponsor:
Information provided by:
Abbott
ClinicalTrials.gov Identifier:
NCT00679653
First received: March 26, 2008
Last updated: May 16, 2008
Last verified: May 2008

March 26, 2008
May 16, 2008
February 2002
December 2003   (final data collection date for primary outcome measure)
  • Systolic Blood Pressure [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
  • Diastolic Blood Pressure [ Time Frame: Duration of Study ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00679653 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives
Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
  • Obesity
  • Hypertension
  • Drug: sibutramine
    8-wks, sibutramine, 10 mg, capsules, once daily
    Other Names:
    • ABT-991
    • Meridia
    • Reductil
    • sibutramine
  • Drug: sibutramine
    8-wks, sibutramine, 15 mg, capsules, once daily
    Other Names:
    • ABT-991
    • Meridia
    • Reductil
    • sibutramine
  • Drug: verapamil/trandolapril
    2 wk Run-in phase, antihypertensive therapy only
    Other Name: verapamil/trandolapril
  • Drug: metoprolol/HCT
    2 wk Run-in phase, antihypertensive therapy only
    Other Name: metoprolol/HCT
  • Drug: felodipine/ramipril
    2 wk Run-in phase, antihypertensive therapy only
    Other Name: felodipine/ramipril
  • Active Comparator: 1
    verapamil/trandolapril
    Interventions:
    • Drug: sibutramine
    • Drug: sibutramine
    • Drug: verapamil/trandolapril
  • Active Comparator: 2
    metoprolol/HCT
    Interventions:
    • Drug: sibutramine
    • Drug: sibutramine
    • Drug: metoprolol/HCT
  • Active Comparator: 3
    felodipine/ramipril
    Interventions:
    • Drug: sibutramine
    • Drug: sibutramine
    • Drug: felodipine/ramipril
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
171
Not Provided
December 2003   (final data collection date for primary outcome measure)

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
Both
20 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00679653
KD200010
No
Prof. Dr. Med J. Scholze, Director of Charite Medical OPD
Abbott
Not Provided
Not Provided
Abbott
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP