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

NCT ID: NCT00420589

Last Updated: 2015-02-05

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-10-31
• Study Completion Date: 2008-11-30

Brief 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.

Conditions

Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

Arm 1: MK0364 Pbo capsules once daily

Group Type: PLACEBO_COMPARATOR

Comparator: placebo

Intervention Type: DRUG

Placebo capsules once daily. Treatment for 52 weeks

2

Arm 2: MK0364 0.5 mg capsule once daily

Group Type: EXPERIMENTAL

taranabant

Intervention Type: DRUG

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

3

Arm 3: MK0364 1 mg capsule once daily

Group Type: EXPERIMENTAL

taranabant

Intervention Type: DRUG

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

4

Arm 4: MK0364 2 mg capsule once daily

Group Type: EXPERIMENTAL

taranabant

Intervention Type: DRUG

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

Interventions

taranabant

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

Intervention Type: DRUG

Comparator: placebo

Placebo capsules once daily. Treatment for 52 weeks

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

References

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 with a low-calorie diet. Obesity (Silver Spring). 2010 Dec;18(12):2301-10. doi: 10.1038/oby.2010.67. Epub 2010 Apr 8.

Reference Type: RESULT

PMID: 20379151 (View on PubMed)

Other Identifiers

2006_512

Identifier Type: -

Identifier Source: secondary_id

0364-012

Identifier Type: -

Identifier Source: org_study_id