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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
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
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
  • Drug: sibutramine
    8-wks, sibutramine, 15 mg, capsules, once daily
    Other Names:
    • ABT-991
    • Meridia
    • Reductil
  • Drug: verapamil/trandolapril
    2 wk Run-in phase, antihypertensive therapy only
  • Drug: metoprolol/HCT
    2 wk Run-in phase, antihypertensive therapy only
  • Drug: felodipine/ramipril
    2 wk Run-in phase, antihypertensive therapy only
  • 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   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00679653
KD200010
No
Not Provided
Not Provided
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