An Investigational Drug Study to Assess Weight Loss in Obese and Overweight Patients (0364-037)(TERMINATED)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Obesity

Treatments: Drug: taranabant; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00384605

0364-037

2006_513

Details and patient eligibility

About

A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

Enrollment: 1,000 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female, 18 years of age or older, with Body Mass Index (BMI) 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). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
• Stable weight (+/-3 kg) for at least 3 months prior to study start

Exclusion criteria

• History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
• Screening systolic blood pressure > 160 mm Hg or diastolic blood pressure > 100 mm Hg

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,000 participants in 4 patient groups, including a placebo group

1

Experimental group

Description:

Arm 1: MK0364 2 mg capsule once daily

Treatment:

Drug: taranabant

2

Experimental group

Description:

Arm 2: MK0364 1 mg capsule once daily

Treatment:

Drug: taranabant

3

Experimental group

Description:

Arm 3: MK0364 0.5 mg capsule once daily.

Treatment:

Drug: taranabant

4

Placebo Comparator group

Description:

Arm 4: Pbo capsule once daily.

Treatment:

Drug: placebo