NCT00384605

Brief Summary

A 1 year worldwide study in obese and overweight patients to assess the safety and effect on body weight of an investigational weight loss drug.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for phase_3 obesity

Timeline
Completed

Started Oct 2006

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

October 1, 2006

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 6, 2006

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

March 13, 2015

Status Verified

March 1, 2015

Enrollment Period

1.3 years

First QC Date

October 3, 2006

Last Update Submit

March 12, 2015

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Body weight after 52 weeks of treatment

    52 weeks

Secondary Outcomes (1)

  • Waist circumference, percent body fat, biochemical markers, blood pressure, and patient-reported outcomes after 52 weeks of treatment

    52 weeks

Study Arms (4)

1

EXPERIMENTAL

Arm 1: MK0364 2 mg capsule once daily

Drug: taranabant

2

EXPERIMENTAL

Arm 2: MK0364 1 mg capsule once daily

Drug: taranabant

3

EXPERIMENTAL

Arm 3: MK0364 0.5 mg capsule once daily.

Drug: taranabant

4

PLACEBO COMPARATOR

Arm 4: Pbo capsule once daily.

Drug: placebo

Interventions

taranabantDRUG

taranabant 0.5 mg capsule, 1 mg capsule, 2 mg capsule once daily. Treatment for 52 weeks.

123
placeboDRUG

Placebo capsule once daily. Treatment for 52 weeks.

4

Eligibility Criteria

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

You may qualify if:

  • Male or female, 18 years of age or older, with Body Mass Index (BMI) 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). Obesity-related comorbidities associated with a BMI of 27 kg/m2 or higher include hypertension, dyslipidemia or sleep apnea
  • Stable weight (+/-3 kg) for at least 3 months prior to study start

You may not qualify if:

  • History of diabetes mellitis, major psychiatric disorder, significant cardiovascular disease, stroke, TIA, neurological disorder, non-febrile seizures
  • Screening systolic blood pressure \> 160 mm Hg or diastolic blood pressure \> 100 mm Hg

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

October 3, 2006

First Posted

October 6, 2006

Study Start

October 1, 2006

Primary Completion

January 1, 2008

Study Completion

December 1, 2008

Last Updated

March 13, 2015

Record last verified: 2015-03