A 2-Year Study of an Investigational Drug in Obese Patien... | NCT00092859

Studies
A 2-Year Study of an Investigational Drug in Obese Patients (0557-011)

NCT00092859

Sponsor

Merck Sharp & Dohme LLC

Status

Completed

Last Update Posted

Jan 2, 2017Estimated

Enrollment

1,500Actual

Phase

Phase 3

Conditions

Obesity

Interventions

MK0557

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Jun 2005Actual

Completion Date

Jun 2005Actual

First Submitted Date

Sep 23, 2004

First Submission Date that Met QC Criteria

Sep 27, 2004

First Posted Date

Sep 28, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Dec 30, 2016

Last Update Posted Date

Jan 2, 2017Estimated

Description Module

Brief Summary

This is a 2-year study to assess the safety, tolerability, and efficacy of an investigational drug in obese patients.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,500Actual

Name	Type	Description	Arm Group Labels	Other Names
MK0557	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Body weight after 1 year of treatment. Safety and tolerability for 2 years.		After 1 & 2 years of treatment

Secondary Outcomes

Measure	Description	Time Frame
Durability of weight loss over two years.		Over two years.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Obese men and nonpregnant women at least 18 years of age with a specific body mass index (height and weight ratio) required by the study

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Medical Monitor	Merck Sharp & Dohme LLC	Study Director

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C515547	spiro(cyclohexane-1,3'(1'H)-furo(3,4-C)pyridine)-4-carboxamide, N-(1-(2-fluorophenyl)-1h-pyrazol-3-yl)-1'-oxo-, trans-

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
MK0557-011
2004_030