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

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Merck Sharp & Dohme Corp.

ClinicalTrials.gov Identifier:

NCT00092872

First received: September 23, 2004

Last updated: January 29, 2015

Last verified: January 2015

History of Changes

Purpose

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	Intervention	Phase
Obesity	Drug: MK0557	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, 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

Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:

Body weight after 1 year of treatment. [ Time Frame: After 1 year of treatment ] [ Designated as safety issue: No ]
Safety and tolerability. [ Time Frame: After 1 year of treatment ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: No ]


Enrollment:	359
Study Start Date:	November 2003
Study Completion Date:	February 2005
Primary Completion Date:	February 2005 (Final data collection date for primary outcome measure)

Eligibility


Ages Eligible for Study:	18 Years to 65 Years (Adult)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00092872

Sponsors and Collaborators

Merck Sharp & Dohme Corp.

Investigators


Study Director:	Medical Monitor	Merck Sharp & Dohme Corp.

More Information

Publications:

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
Study First Received:	September 23, 2004
Last Updated:	January 29, 2015
Health Authority:	United States: Food and Drug Administration

ClinicalTrials.gov processed this record on September 29, 2016

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