NCT00131430

Brief Summary

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

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

Timeline
Completed

Started Aug 2005

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

August 1, 2005

Completed
15 days 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
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2007

Completed
Last Updated

June 7, 2016

Status Verified

March 1, 2016

Enrollment Period

1.7 years

First QC Date

August 16, 2005

Last Update Submit

June 6, 2016

Conditions

Obesity and Obesity-related Medical Conditions

Outcome Measures

Primary Outcomes (1)

  • After 24 weeks, body weight, safety, and tolerability

    After 24 weeks

Secondary Outcomes (1)

  • After 80 weeks, body weight

    After 80 weeks

Interventions

taranabantDRUG
Also known as: MK0364

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 30kg/m2 and 43 kg/m2, inclusive (BMI between 27 kg/m2 and 43kg/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

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

August 16, 2005

First Posted

August 18, 2005

Study Start

August 1, 2005

Primary Completion

May 1, 2007

Study Completion

May 1, 2007

Last Updated

June 7, 2016

Record last verified: 2016-03