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

NCT00420589

0364-012

2006_512

Details and patient eligibility

About

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

Enrollment: 1,000 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

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

Placebo Comparator group

Description:

Arm 1: MK0364 Pbo capsules once daily

Treatment:

Drug: Comparator: placebo

2

Experimental group

Description:

Arm 2: MK0364 0.5 mg capsule once daily

Treatment:

Drug: taranabant

3

Experimental group

Description:

Arm 3: MK0364 1 mg capsule once daily

Treatment:

Drug: taranabant

4

Experimental group

Description:

Arm 4: MK0364 2 mg capsule once daily

Treatment:

Drug: taranabant