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

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Obesity

Treatments: Drug: taranabant; Drug: Comparator: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131404

2005_031

0364-015

Details and patient eligibility

About

A study to determine the safety and efficacy of an investigational drug in patients with obesity plus extension.

Enrollment: 2,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,400 participants in 5 patient groups, including a placebo group

Phase A/B: Arm 1

Placebo Comparator group

Description:

Phase A: Arm 1: MK0364 Pbo capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 1: MK0364 Pbo capsule once daily.

Treatment:

Drug: Comparator: Placebo

Phase A/B: Arm 2

Experimental group

Description:

Phase A: Arm 2: MK0364 2 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 2: MK0364 2 mg capsule once daily.

Treatment:

Drug: taranabant

Phase A/B: Arm 3

Experimental group

Description:

Phase A: Arm 3: MK0364 4 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 3: MK0364 4 mg capsule once daily.

Treatment:

Drug: taranabant

Phase A/B: Arm 4

Experimental group

Description:

Phase A: Arm 4: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 4: MK0364 6 mg capsule once daily.

Treatment:

Drug: taranabant

Phase A/B: Arm 5

Experimental group

Description:

Phase A: Arm 5: MK0364 6 mg capsule once daily. 52 week treatment period. Phase B: Patients who continue into Phase B will remain in the same arm they were assigned to during Phase A and will receive the following: Arm 5: MK0364 6 mg capsule once daily.

Treatment:

Drug: taranabant