An Eighteen Month Efficacy and Safety Study in Obese Patients (0364-020)(COMPLETED)

A study to determine the safety and efficacy of an investigational drug in patients with obesity.

Completed

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Key information

Conditions

Obesity and Obesity-related Medical Conditions Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Obese patients with a body mass index between 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/m2, inclusive for those with obesity-related comorbidities including hypertension, dyslipidemia and sleep apnea).

Exclusion criteria

Patients with serious or unstable current or past medical conditions.

Treatment and study plan

taranabant

Drug

Other names: MK0364

Primary outcomes

After 24 weeks, body weight, safety, and tolerability

Time frame: After 24 weeks

Secondary outcomes

After 80 weeks, body weight

Time frame: After 80 weeks

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An 18-Month Study to Assess the Safety, Tolerability, and Efficacy of MK0364 in Obese Patients

Important dates

Study start: 2005
Primary completion: 2007
Study completion: 2007
First posted: Aug 18, 2005
Registry last updated: Jun 7, 2016

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.

Published trials that share one or more normalized conditions with this study.

Completed