Trial record 1 of 1 for: NCT00376285

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Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033

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ClinicalTrials.gov Identifier: NCT00376285

Recruitment Status : Withdrawn

First Posted : September 14, 2006

Last Update Posted : April 22, 2015

Sponsor:

Information provided by (Responsible Party):

Pfizer

Tracking Information

First Submitted Date ^ICMJE

September 13, 2006

First Posted Date ^ICMJE

September 14, 2006

Last Update Posted Date

April 22, 2015

Study Start Date ^ICMJE

November 2006

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Toleration and safety

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

Efficacy biomarkers, serum lipids

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033

Official Title ^ICMJE

A Phase 1, Randomized, Investigator and Subject Blind, Sponsor Open Study to Determine the Effects of Fenofibrate on the Safety, Toleration and Efficacy Biomarkers of CP-742,033 When Co-Administered in Otherwise Healthy Obese Adult Subjects

Brief Summary

The purpose of this study is to determine whether fenofibrate effects the toleration, safety, or efficacy biomarkers of CP-742,033, a drug being developed for the treatment of obesity.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 1

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Treatment

Condition ^ICMJE

Obesity

Intervention ^ICMJE

Drug: CP-742,033
Drug: Fenofibrate

Study Arms ^ICMJE

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Actual Enrollment ^ICMJE

Original Enrollment ^ICMJE

Study Completion Date ^ICMJE

Not Provided

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

BMI of 30-40 kg/m2

Exclusion Criteria:

Women of childbearing potential

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years to 65 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Not Provided

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00376285

Other Study ID Numbers ^ICMJE

A5431015

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

Pfizer

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

PRS Account

Pfizer

Verification Date

April 2015

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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