An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)

Obesity Clinical Trial

Official title:

A Phase III Randomized, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of Taranabant (MK0364) in Obese Patients and in Overweight Patients With Obesity-Related Co-Morbidities, Followed by a 1-Year Extension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00384605
• Other study ID #: 0364-037
• Secondary ID: 2006_513
• Status: Terminated
• Phase: Phase 3
• First received: October 3, 2006
• Last updated: March 12, 2015
• Start date: October 2006
• Est. completion date: December 2008

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: December 2008
• Est. primary completion date: January 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Male or female, 18 years of age or older, with Body Mass Index (BMI) between 30 kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43 kg/m2, inclusive, for those with obesity-related comorbidities). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea

• Stable weight (+/-3 kg) for at least 3 months prior to study start

Exclusion Criteria:

• History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures

• Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• taranabant
taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.
• placebo
Placebo capsule once daily. Treatment for 52 weeks.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight after 52 weeks of treatment		52 weeks	No
Secondary	Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment		52 weeks	No