A Weight Maintenance Study in Obese Patients (0364-012)(TERMINATED)

Obesity Clinical Trial

Official title:

A Study to Assess the Efficacy and Tolerability of Taranabant in Maintaining Weight Loss Induced by Diet in Obese Patients Followed by a 1-Year Extension

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00420589
• Other study ID #: 0364-012
• Secondary ID: 2006_512
• Status: Terminated
• Phase: Phase 3
• First received: January 5, 2007
• Last updated: February 4, 2015
• Start date: October 2006
• Est. completion date: November 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

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1000
• Est. completion date: November 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start

• Patient is male or female >=18 and <= 65 years of age

• Patient understands the study procedures and alternative treatments available

• Patient is able to read, understand and complete study questionnaires

Exclusion Criteria:

• Patient has a history or presence of a major psychiatric disorder

• Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder

• Patient has a history of seizures or is at high risk of developing seizures

• Patient has systolic blood pressure >160mm Hg or diastolic blood pressure > 100 mm Hg

• Patient has diabetes mellitus as defined by medical history

Study Design

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

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.
• Comparator: placebo
Placebo capsules once daily. Treatment for 52 weeks

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

Wadden TA, Fujioka K, Toubro S, Gantz I, Erondu NE, Chen M, Suryawanshi S, Carofano W, Johnson-Levonas AO, Shapiro DR, Kaufman KD, Heymsfield SB, Amatruda JM. A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Body weight at 52 weeks, safety and tolerability.		52 weeks	Yes
Secondary	Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.		52 weeks	No