NCT00131404

Brief Summary

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

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 Sep 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

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
14 days until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

1.4 years

First QC Date

August 16, 2005

Last Update Submit

February 4, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Decreases body weight; safety and tolerability

    156 Weeks

Secondary Outcomes (1)

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

    156 Weeks

Study Arms (5)

Phase A/B: Arm 1

PLACEBO COMPARATOR

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.

Drug: Comparator: Placebo

Phase A/B: Arm 2

EXPERIMENTAL

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.

Drug: taranabant

Phase A/B: Arm 3

EXPERIMENTAL

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.

Drug: taranabant

Phase A/B: Arm 4

EXPERIMENTAL

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.

Drug: taranabant

Phase A/B: Arm 5

EXPERIMENTAL

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.

Drug: taranabant

Interventions

taranabantDRUG

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

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

Placebo capsule once daily. 52 week treatment period.

Phase A/B: Arm 1

Eligibility Criteria

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

You may qualify if:

  • 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

You may not qualify if:

  • Patients with serious or unstable current or past medical conditions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Aronne LJ, Tonstad S, Moreno M, Gantz I, Erondu N, Suryawanshi S, Molony C, Sieberts S, Nayee J, Meehan AG, Shapiro D, Heymsfield SB, Kaufman KD, Amatruda JM. A clinical trial assessing the safety and efficacy of taranabant, a CB1R inverse agonist, in obese and overweight patients: a high-dose study. Int J Obes (Lond). 2010 May;34(5):919-35. doi: 10.1038/ijo.2010.21. Epub 2010 Feb 16.

    PMID: 20157323RESULT

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

September 1, 2005

Primary Completion

February 1, 2007

Study Completion

December 1, 2008

Last Updated

February 5, 2015

Record last verified: 2015-02