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OpenTrials
Completed

NCT Number: NCT00679653

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.

Completed

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Key information

Conditions

Obesity Body Weight Cardiovascular Diseases Hypertension Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

sibutramine

Drug

8-wks, sibutramine, 10 mg, capsules, once daily

Other names: ABT-991, Meridia, Reductil

verapamil/trandolapril

Drug

2 wk Run-in phase, antihypertensive therapy only

metoprolol/HCT

Drug

2 wk Run-in phase, antihypertensive therapy only

felodipine/ramipril

Drug

2 wk Run-in phase, antihypertensive therapy only

Primary outcomes

  1. Systolic Blood Pressure

    Time frame: Duration of Study

  2. Diastolic Blood Pressure

    Time frame: Duration of Study

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Acronym: HOS

Important dates

Study start
2002
Primary completion
2003
First posted
May 19, 2008
Registry last updated
May 19, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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