NCT00420589

Brief Summary

To compare the effects of taranabant versus placebo on weight regain and weight maintenance after low calorie diet-induced weight loss in obese patients.

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
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 11, 2007

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2008

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

February 5, 2015

Status Verified

February 1, 2015

Enrollment Period

1.3 years

First QC Date

January 5, 2007

Last Update Submit

February 4, 2015

Conditions

Obesity

Keywords

Weight lossWeight regainWeight maintenance

Outcome Measures

Primary Outcomes (1)

  • Body weight at 52 weeks, safety and tolerability.

    52 weeks

Secondary Outcomes (1)

  • Body weight, biochemical markers, blood pressure, waist circumference and patient reported outcomes at 52 weeks.

    52 weeks

Study Arms (4)

1

PLACEBO COMPARATOR

Arm 1: MK0364 Pbo capsules once daily

Drug: Comparator: placebo

2

EXPERIMENTAL

Arm 2: MK0364 0.5 mg capsule once daily

Drug: taranabant

3

EXPERIMENTAL

Arm 3: MK0364 1 mg capsule once daily

Drug: taranabant

4

EXPERIMENTAL

Arm 4: MK0364 2 mg capsule once daily

Drug: taranabant

Interventions

taranabantDRUG

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

234
Comparator: placeboDRUG

Placebo capsules once daily. Treatment for 52 weeks

1

Eligibility Criteria

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

You may qualify if:

  • Patient has a body mass index (BMI) between 30 kg/m² and 43kg/m² and has maintained a stable weight (+/- 3kg) for at least 3 months prior to study start
  • Patient is male or female \>=18 and \<= 65 years of age
  • Patient understands the study procedures and alternative treatments available
  • Patient is able to read, understand and complete study questionnaires

You may not qualify if:

  • Patient has a history or presence of a major psychiatric disorder
  • Patient has a recent history (within 6 months prior to signing the informed consent) diagnosis/episode/recurrence of stroke, TIA or neurological disorder
  • Patient has a history of seizures or is at high risk of developing seizures
  • Patient has systolic blood pressure \>160mm Hg or diastolic blood pressure \> 100 mm Hg
  • Patient has diabetes mellitus as defined by medical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wadden TA, Fujioka K, Toubro S, Gantz I, Erondu NE, Chen M, Suryawanshi S, Carofano W, Johnson-Levonas AO, Shapiro DR, Kaufman KD, Heymsfield SB, Amatruda JM. A randomized trial of lifestyle modification and taranabant for maintaining weight loss achieved with a low-calorie diet. Obesity (Silver Spring). 2010 Dec;18(12):2301-10. doi: 10.1038/oby.2010.67. Epub 2010 Apr 8.

    PMID: 20379151RESULT

MeSH Terms

Conditions

ObesityWeight Loss

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 SymptomsBody Weight Changes

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
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2007

First Posted

January 11, 2007

Study Start

October 1, 2006

Primary Completion

February 1, 2008

Study Completion

November 1, 2008

Last Updated

February 5, 2015

Record last verified: 2015-02