A Study of MK0364 in Obese Patients (0364-014)

Obesity Clinical Trial

Official title:

A 2-Year Study (1-Year Weight Loss Followed by 1-Year Prevention of Weight Regain) to Assess the Safety, Tolerability and Efficacy of Taranabant (MK0364) in Obese Patients Followed by a 1-Year Extension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00131391
• Other study ID #: 0364-014
• Secondary ID: 2005_034
• Status: Terminated
• Phase: Phase 3
• First received: August 16, 2005
• Last updated: April 2, 2015
• Start date: July 2005
• Est. completion date: December 2008

Study information

• Verified date: April 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 worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2400
• Est. completion date: December 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Body Mass Index (BMI) between 30-43 kg/m2

Exclusion Criteria:

• History of major psychiatric disorder

• History of seizures or at high risk of developing seizures

• Blood pressure greater than 160/100

• Fasting blood glucose greater than 126 mg/dL

• Triglycerides greater than 600 mg/dL

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:
• Comparator: taranabant
taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.
• Comparator: placebo
Placebo capsule once daily . 52 week treatment period.

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	Decreases body weight; prevention of weight regain; safety and tolerability		2 Years	Yes
Secondary	Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity		2 Years	No