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

Verified by: Abbott, May 2008
First Received: March 26, 2008 | Last Updated: May 16, 2008 | Phase: Phase 3 | Start Date: February 2002
Overall Status: Completed | Estimated Enrollment: 171
  • …
  • Tell a FriendPrint

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...

Brief Summary

Official Title: “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.

  • Study Type: Interventional
  • Study Design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
  • Study Primary Completion Date: December 2003

Intervention(s) in this Clinical Trial

  • Drug: sibutramine
    • 8-wks, sibutramine, 10 mg, capsules, once daily
  • Drug: sibutramine
    • 8-wks, sibutramine, 15 mg, capsules, once daily
  • 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

Arms, Groups and Cohorts in this Clinical Trial

  • Active Comparator: 1
    • verapamil/trandolapril
  • Active Comparator: 2
    • metoprolol/HCT
  • Active Comparator: 3
    • felodipine/ramipril

Outcome Measures for this Clinical Trial

Primary Measures

  • Systolic Blood Pressure
    • Time Frame: Duration of Study
      Safety Issue?: Yes
  • Diastolic Blood Pressure
    • Time Frame: Duration of Study
      Safety Issue?: Yes

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Abbott Industry

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00679653

Study ID Number: KD200010

ClinicalTrials.gov Identifier: NCT00679653

Health Authority: Germany: Ministry of Health

  • …
  • Tell a FriendPrint

Clinical Trials content is provided directly by the U.S. National Institutes of Health via ClinicalTrials.gov and is not reviewed separately by ClinicalTrialsFeeds.org. Every page of specific clinical trials information contains a unique identifier which can be used to find further details directly from the National Institutes of Health.

The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00679653