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A 1-Year Study of an Investigational Drug in Obese Patients (0557-012)(COMPLETED)
This study has been completed.
Sponsor:
Merck Sharp & Dohme Corp.
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
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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 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 |
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 ]
- 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 ]
| 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) |
| 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
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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
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:
| 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 |
ClinicalTrials.gov processed this record on September 21, 2017