Effect of CP-778,875 on HDL-C in Subjects With Abnormal Lipid Levels and Type 2 Diabetes.
NCT00326326
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- 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
- Known cardiovascular, carotid, or peripheral vascular disease
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Descriptive Information | ||||
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Brief Title ICMJE | Effect of CP-778,875 on HDL-C in Subjects With Abnormal Lipid Levels and Type 2 Diabetes. | |||
Official Title ICMJE | 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 | |||
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 | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Dyslipidemia | |||
Intervention ICMJE | Drug: CP-778,875 | |||
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 | Completed | |||
Enrollment ICMJE | 84 | |||
Original Enrollment ICMJE | Same as current | |||
Actual Study Completion Date ICMJE | June 2007 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 30 Years to 70 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers ICMJE | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00326326 | |||
Other Study ID Numbers ICMJE | A5561005 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | Pfizer | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
| |||
PRS Account | Pfizer | |||
Verification Date | May 2009 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |