Effect of CP-778,875 on HDL-C in Subjects With Abnormal L... | NCT00326326 | Trialant

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Effect of CP-778,875 on HDL-C in Subjects With Abnormal L... | NCT00326326 | Trialant

Studies
Effect of CP-778,875 on HDL-C in Subjects With Abnormal Lipid Levels and Type 2 Diabetes.

NCT00326326

Sponsor

Pfizer

Status

Completed

Last Update Posted

May 7, 2009Estimated

Enrollment

84

Phase

Phase 2

Conditions

Dyslipidemia

Interventions

CP-778,875

Countries

United States

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

NCT00326326

Obsolete or Duplicate NCT IDs

Not provided

Organization Study

A5561005

Secondary IDs

Not provided

Brief Title

Effect of CP-778,875 on HDL-C in Subjects With Abnormal Lipid Levels and Type 2 Diabetes.

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled Study To Evaluate The Effect Of CP-778,875 On HDL-Cholesterol In Adult Subjects With Dyslipidemia And Type 2 Diabetes Mellitus

Acronym

Not provided

Organization

PfizerINDUSTRY

Status Module

Record Verification Date

May 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2006

Primary Completion Date

Not provided

Completion Date

Jun 2007Actual

First Submitted Date

May 12, 2006

First Submission Date that Met QC Criteria

May 12, 2006

First Posted Date

May 16, 2006Estimated

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

May 6, 2009

Last Update Posted Date

May 7, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

PfizerINDUSTRY

Collaborators

Not provided

Oversight Module

No data available

No data is available for this block.

Description Module

Brief Summary

To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia and type 2 diabetes

Detailed Description

Not provided

Conditions Module

Conditions

Dyslipidemia

Keywords

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

84

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
CP-778,875	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HDL-C Safety and Efficacy

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HDL-C < or = 45 mg/dL for men and < or = 55 mg/dL for women
Triglycerides between 150-500 mg/dL
Fasting Plasma Glucose 140-240 mg/dL

Exclusion Criteria:

Known cardiovascular, carotid, or peripheral vascular disease

Accepts Healthy Volunteers

No

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pfizer CT.gov Call Center	Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Pfizer Investigational Site		Anniston	Alabama	36207	United States
Pfizer Investigational Site

References Module

Citations

Not provided

See Also Links

Label	URL
To obtain contact information for a study center near you, click here.	View source

Available IPD Information

Not provided

IPD Sharing Statement Module

No data available

No data is available for this block.

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

Jul 10, 2026

Removed Countries

Not provided

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

MeSH Terms

Intervention Browse Module

No data available

No data is available for this block.

Randomized

Intervention Model

Parallel Assignment

Intervention Model Description

Not provided

Primary Purpose

Treatment

Observational Model

Not provided

Time Perspective

Not provided

Masking Info

Masking

Double

Masking Description

Not provided

Who Masked

Not provided

Huntsville

Alabama

35801

United States

Pfizer Investigational Site

Greenbrae

California

94904

United States

Pfizer Investigational Site

Los Angeles

California

90057

United States

Pfizer Investigational Site

Walnut Creek

California

94598

United States

Pfizer Investigational Site

DeFuniak Springs

Florida

32435

United States

Pfizer Investigational Site

Destin

Florida

32541

United States

Pfizer Investigational Site

Jupiter

Florida

33458

United States

Pfizer Investigational Site

Melbourne

Florida

32901

United States

Pfizer Investigational Site

Atlanta

Georgia

30342

United States

Pfizer Investigational Site

Conyers

Georgia

30094

United States

Pfizer Investigational Site

Chicago

Illinois

60612

United States

Pfizer Investigational Site

Iowa City

Iowa

52242

United States

Pfizer Investigational Site

Lexington

Kentucky

40504

United States

Pfizer Investigational Site

Baltimore

Maryland

21201

United States

Pfizer Investigational Site

Springfield

Missouri

65807

United States

Pfizer Investigational Site

Omaha

Nebraska

68131

United States

Pfizer Investigational Site

Las Vegas

Nevada

89106

United States

Pfizer Investigational Site

Mount Vernon

New York

10550

United States

Pfizer Investigational Site

Oklahoma City

Oklahoma

73103

United States

Pfizer Investigational Site

Tulsa

Oklahoma

74136

United States

Pfizer Investigational Site

Kingsport

Tennessee

37660

United States

Pfizer Investigational Site

Bryan

Texas

77802

United States

Pfizer Investigational Site

Houston

Texas

77030

United States

Pfizer Investigational Site

San Antonio

Texas

78229

United States

Pfizer Investigational Site

Newport News

Virginia

23606

United States

Pfizer Investigational Site

Richmond

Virginia

23225

United States

Pfizer Investigational Site

Richmond

Virginia

23249

United States

Pfizer Investigational Site

Richmond

Virginia

23294

United States

Pfizer Investigational Site

Yakima

Washington

98902

United States

Pfizer Investigational Site

Milwaukee

Wisconsin

53209

United States

ID	Term
D050171	Dyslipidemias

Ancestor Terms

ID	Term
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided