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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Obesity
Hypertension
 Drug: sibutramine
Drug: verapamil/trandolapril
Drug: metoprolol/HCT
Drug: felodipine/ramipril
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Blood Pressure and Weight Trajectory on a Dual Antihypertensive Combination Plus Sibutramine Versus Placebo in Obese Hypertensives

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Abbott:

Primary Outcome Measures:
  • 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 ]

Enrollment: 171
Study Start Date: February 2002
Primary Completion Date: December 2003 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
verapamil/trandolapril
 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
Active Comparator: 2
metoprolol/HCT
 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: metoprolol/HCT
2 wk Run-in phase, antihypertensive therapy only
Other Name: metoprolol/HCT
Active Comparator: 3
felodipine/ramipril
 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: felodipine/ramipril
2 wk Run-in phase, antihypertensive therapy only
Other Name: felodipine/ramipril

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Prof. Dr. Med J. Scholze, Director of Charite Medical OPD
ClinicalTrials.gov Identifier: NCT00679653     History of Changes
Other Study ID Numbers: KD200010
Study First Received: March 26, 2008
Last Updated: May 16, 2008
Health Authority: Germany: Ministry of Health

Additional relevant MeSH terms:
Hypertension
Obesity
Vascular Diseases
Cardiovascular Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Trandolapril
Antihypertensive Agents
Metoprolol
Diltiazem
Felodipine
Ramipril
 Verapamil
Metoprolol succinate
Sibutramine
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Arrhythmia Agents
Sympatholytics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Adrenergic beta-1 Receptor Antagonists
Adrenergic beta-Antagonists
Adrenergic Antagonists
Adrenergic Agents

ClinicalTrials.gov processed this record on May 22, 2013