A Two Year Safety and Efficacy Study in Obese Patients (0364-015)(TERMINATED)

Obesity Clinical Trial

Official title:

A 2-Year Study to Assess the Efficacy, Safety, and Tolerability of Taranabant in Obese Patients Followed by a 1-Year Extension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00131404
• Other study ID #: 0364-015
• Secondary ID: 2005_031
• Status: Terminated
• Phase: Phase 3
• First received: August 16, 2005
• Last updated: February 4, 2015
• Start date: September 2005
• Est. completion date: December 2008

Study information

• Verified date: February 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 study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2400
• Est. completion date: December 2008
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Obese patients with a body mass index 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 including hypertension, dyslipidemia, and sleep apnea

Exclusion Criteria:

• Patients with serious or unstable current or past medical conditions

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 2 mg capsule, 4 mg capsule, 6 mg capsule once daily. 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.

References & Publications (1)

Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obe — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Decreases body weight; safety and tolerability		156 Weeks	Yes
Secondary	Decreases waist circumference, the proportion of patients with metabolic syndrome, triglycerides, non-HDL-C, LDL-C, fasting insulin, FPG; increases HDL-C, insulin sensitivity		156 Weeks	No