A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)

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ClinicalTrials.gov Identifier: NCT00092872

Recruitment Status : Completed

First Posted : September 28, 2004

Last Update Posted : January 30, 2015

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

Study Description

Brief Summary:

This is a 1-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients after a very low calorie diet.

Condition or disease	Intervention/treatment	Phase
Obesity	Drug: MK0557	Phase 3

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	359 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Double-Blind, Randomized, Placebo-Controlled, Multicenter Study to Assess the Safety, Tolerability, and Efficacy of MK0557 in Obese Patients
Study Start Date :	November 2003
Actual Primary Completion Date :	February 2005
Actual Study Completion Date :	February 2005

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Body weight after 1 year of treatment. [ Time Frame: After 1 year of treatment ]
Safety and tolerability. [ Time Frame: After 1 year of treatment ]

Secondary Outcome Measures :

Waist circumference; Blood pressure, body fat mass, biochemical markers (fasting plasma, lipid profile, fasting plasma glucose, leptin, insulin, insulin sensitivity); body weight after 2 years [ Time Frame: After 2 years ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years to 65 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Obese men and nonpregnant women between the ages of 18 and 65 years with a body mass index (height to weight ratio) as required by the study.

Exclusion Criteria:

Patients with uncontrolled high blood pressure and/or diabetes mellitus (high blood sugar)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00092872

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications of Results:

Erondu N, Gantz I, Musser B, Suryawanshi S, Mallick M, Addy C, Cote J, Bray G, Fujioka K, Bays H, Hollander P, Sanabria-Bohórquez SM, Eng W, Långström B, Hargreaves RJ, Burns HD, Kanatani A, Fukami T, MacNeil DJ, Gottesdiener KM, Amatruda JM, Kaufman KD, Heymsfield SB. Neuropeptide Y5 receptor antagonism does not induce clinically meaningful weight loss in overweight and obese adults. Cell Metab. 2006 Oct;4(4):275-82.


Responsible Party:	Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:	NCT00092872 History of Changes
Other Study ID Numbers:	0557-012 MK0557-012 2004_031
First Posted:	September 28, 2004 Key Record Dates
Last Update Posted:	January 30, 2015
Last Verified:	January 2015

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