NCT00533481

Brief Summary

Study medicine will be given alone, or in combination with either sibutramine or orlistat, to obese subjects to compare the effect on body weight over a six month period.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
497

participants targeted

Target at P75+ for phase_2 obesity

Timeline
Completed

Started Feb 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

February 1, 2004

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2004

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2004

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 19, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 21, 2007

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

10 months

First QC Date

September 19, 2007

Last Update Submit

September 15, 2016

Conditions

Obesity

Interventions

MK0557DRUG

Eligibility Criteria

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

You may qualify if:

  • Men and women between the ages of 18-65 who are considered obese (have a body mass index between 30 and 43)

You may not qualify if:

  • Subject has high blood pressure or is taking any high blood pressure medicine
  • History of psychiatric disorder, stroke, or heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Obesity

Interventions

spiro(cyclohexane-1,3'(1'H)-furo(3,4-C)pyridine)-4-carboxamide, N-(1-(2-fluorophenyl)-1h-pyrazol-3-yl)-1'-oxo-, trans-

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
FACTORIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 19, 2007

First Posted

September 21, 2007

Study Start

February 1, 2004

Primary Completion

December 1, 2004

Study Completion

December 1, 2004

Last Updated

September 16, 2016

Record last verified: 2016-09