NCT00109148

Brief Summary

The purpose of this study is to determine the safety and effectiveness of an investigational drug in patients with obesity (considerably overweight).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
500

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Jul 2004

Shorter than P25 for phase_2 obesity

Status
completed

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, 2004

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2005

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2005

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 25, 2005

Completed
Last Updated

September 9, 2015

Status Verified

September 1, 2015

Enrollment Period

6 months

First QC Date

April 22, 2005

Last Update Submit

September 8, 2015

Conditions

Obesity

Keywords

Obesity and obesity-related medical conditions

Interventions

MK0364DRUG

Eligibility Criteria

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

You may qualify if:

  • Patients who are obese (considerably overweight) based on body mass index.

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)

  • Addy C, Wright H, Van Laere K, Gantz I, Erondu N, Musser BJ, Lu K, Yuan J, Sanabria-Bohorquez SM, Stoch A, Stevens C, Fong TM, De Lepeleire I, Cilissen C, Cote J, Rosko K, Gendrano IN 3rd, Nguyen AM, Gumbiner B, Rothenberg P, de Hoon J, Bormans G, Depre M, Eng WS, Ravussin E, Klein S, Blundell J, Herman GA, Burns HD, Hargreaves RJ, Wagner J, Gottesdiener K, Amatruda JM, Heymsfield SB. The acyclic CB1R inverse agonist taranabant mediates weight loss by increasing energy expenditure and decreasing caloric intake. Cell Metab. 2008 Jan;7(1):68-78. doi: 10.1016/j.cmet.2007.11.012.

    PMID: 18177726DERIVED

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 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2005

First Posted

April 25, 2005

Study Start

July 1, 2004

Primary Completion

January 1, 2005

Study Completion

February 1, 2005

Last Updated

September 9, 2015

Record last verified: 2015-09