NCT00131391

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,400

participants targeted

Target at P75+ for phase_3 obesity

Timeline
Completed

Started Jul 2005

Longer than P75 for phase_3 obesity

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 16, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 18, 2005

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

April 3, 2015

Status Verified

April 1, 2015

Enrollment Period

2.6 years

First QC Date

August 16, 2005

Last Update Submit

April 2, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Decreases body weight; prevention of weight regain; safety and tolerability

    2 Years

Secondary Outcomes (1)

  • Decreases waist circumference, decreases the proportion of patients with metabolic syndrome, decreases triglycerides, decreases non-HDL-C, decreases LDL-C, decreases fasting insulin, decreases FPG; increases HDL-C, increases insulin sensitivity

    2 Years

Study Arms (6)

Phase A/B; Arm 1

PLACEBO COMPARATOR

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.

Drug: Comparator: placebo

Phase A/B: Arm 2

EXPERIMENTAL

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.

Drug: Comparator: taranabant

Phase A/B: Arm 3

EXPERIMENTAL

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.

Drug: Comparator: taranabantDrug: Comparator: placebo

Phase A/B: Arm 4

EXPERIMENTAL

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.

Drug: Comparator: taranabant

Phase A/B: Arm 5

EXPERIMENTAL

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.

Drug: Comparator: taranabant

Phase A/B: Arm 6

EXPERIMENTAL

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.

Drug: Comparator: taranabant

Interventions

Comparator: taranabantDRUG

taranabant 2 mg capsule, 4 mg capsule, 6 mg capsule. 52 week treatment period.

Also known as: MK0364
Phase A/B: Arm 2Phase A/B: Arm 3Phase A/B: Arm 4Phase A/B: Arm 5Phase A/B: Arm 6
Comparator: placeboDRUG

Placebo capsule once daily . 52 week treatment period.

Phase A/B: Arm 3Phase A/B; Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

N-(3-(4-chlorophenyl)-2-(3-cyanophenyl)-1-methylpropyl)-2-methyl-2-((5-(trifluoromethyl)pyridin-2-yl)oxy)propanamide

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2005

First Posted

August 18, 2005

Study Start

July 1, 2005

Primary Completion

February 1, 2008

Study Completion

December 1, 2008

Last Updated

April 3, 2015

Record last verified: 2015-04