A Study of MK0364 in Obese Patients (0364-014)

Merck Sharp & Dohme (MSD)

Status and phase: Terminated; Phase 3

Conditions: Obesity

Treatments: Drug: Comparator: placebo; Drug: Comparator: taranabant

Study type: Interventional

Funder types: Industry

Identifiers

NCT00131391

0364-014

2005_034

Details and patient eligibility

About

A worldwide study in obese patients to assess the efficacy, safety, and tolerability of an investigational drug.

Enrollment: 2,400 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Body Mass Index (BMI) between 30-43 kg/m2

Exclusion criteria

• History of major psychiatric disorder
• History of seizures or at high risk of developing seizures
• Blood pressure greater than 160/100
• Fasting blood glucose greater than 126 mg/dL
• Triglycerides greater than 600 mg/dL

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,400 participants in 6 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 Part B will remain in the same treatment arm they were assigned to in Part 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 4 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 2: MK0364 4 mg capsule once daily.

Treatment:

Drug: Comparator: taranabant

Phase A/B: Arm 3

Experimental group

Description:

Phase A: Arm 3: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 3: MK0364 Pbo capsule once daily.

Treatment:

Drug: Comparator: placebo

Drug: Comparator: 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 Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 4: MK0364 2 mg capsule once daily.

Treatment:

Drug: Comparator: taranabant

Phase A/B: Arm 5

Experimental group

Description:

Phase A: Arm 5: MK0364 6 mg capsule once daily. Phase B: Patients who continue into Part B will remain in the same treatment arm they were assigned to in Part A and will receive the following: Arm 5: MK0364 4 mg capsule once daily.

Treatment:

Drug: Comparator: taranabant

Phase A/B: Arm 6

Experimental group

Description:

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

Treatment:

Drug: Comparator: taranabant