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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:
ClinicalTrials.gov Identifier:
NCT00679653
First Posted: May 19, 2008
Last Update Posted: May 19, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Abbott
  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 (Participant, 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:


Further study details as provided by Abbott:

Primary Outcome Measures:
  • Systolic Blood Pressure [ Time Frame: Duration of Study ]
  • Diastolic Blood Pressure [ Time Frame: Duration of Study ]

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
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
Active Comparator: 2
metoprolol/HCT
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: metoprolol/HCT
2 wk Run-in phase, antihypertensive therapy only
Active Comparator: 3
felodipine/ramipril
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: felodipine/ramipril
2 wk Run-in phase, antihypertensive therapy only

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Responsible Party: Prof. Dr. Med J. Scholze, Director of Charite Medical OPD
ClinicalTrials.gov Identifier: NCT00679653     History of Changes
Other Study ID Numbers: KD200010
First Submitted: March 26, 2008
First Posted: May 19, 2008
Last Update Posted: May 19, 2008
Last Verified: May 2008

Additional relevant MeSH terms:
Metoprolol
Verapamil
Felodipine
Trandolapril
Antihypertensive Agents
Ramipril
Sibutramine
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
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Calcium Channel Blockers
Membrane Transport Modulators
Vasodilator Agents
Antidepressive Agents
Psychotropic Drugs
Appetite Depressants
Anti-Obesity Agents