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

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ClinicalTrials.gov Identifier: NCT00679653
Recruitment Status : Completed
First Posted : May 19, 2008
Last Update Posted : May 19, 2008
Sponsor:
Information provided by:
Abbott

Brief Summary:
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 or disease Intervention/treatment Phase
Obesity Hypertension Drug: sibutramine Drug: verapamil/trandolapril Drug: metoprolol/HCT Drug: felodipine/ramipril Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 171 participants
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
Study Start Date : February 2002
Actual Primary Completion Date : December 2003

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Systolic Blood Pressure [ Time Frame: Duration of Study ]
  2. Diastolic Blood Pressure [ Time Frame: Duration of Study ]


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Ages Eligible for Study:   20 Years to 65 Years   (Adult, Older 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

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 Posted: May 19, 2008    Key Record Dates
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