DyslipidemiaPhase 2NCT00326326
Effect of CP-778,875 on HDL-C in Subjects With Abnormal Lipid Levels and Type 2 Diabetes.
A Phase 2 study testing CP-778,875 in people with Dyslipidemia, run by Pfizer at 31 sites in United States.
Trial summary
To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia and type 2 diabetes Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Dyslipidemia
- What is being tested?
- CP-778,875
- How many people
- 84 participants
- Where
- 31 sitesUnited States
- Study dates
- Jul 2006to Jun 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Known cardiovascular, carotid, or peripheral vascular disease
Trial locations and contacts
31 sites in 1 country.
31 sites in 1 country
United States31 sites
Pfizer Investigational Site
Anniston, Alabama, 36207
Pfizer Investigational Site
Atlanta, Georgia, 30342
Pfizer Investigational Site
Baltimore, Maryland, 21201
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Chicago, Illinois, 60612
Pfizer Investigational Site
Conyers, Georgia, 30094
Pfizer Investigational Site
DeFuniak Springs, Florida, 32435
Pfizer Investigational Site
Destin, Florida, 32541
Pfizer Investigational Site
Greenbrae, California, 94904
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Huntsville, Alabama, 35801
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Jupiter, Florida, 33458
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Las Vegas, Nevada, 89106
Pfizer Investigational Site
Lexington, Kentucky, 40504
Pfizer Investigational Site
Los Angeles, California, 90057
Pfizer Investigational Site
Melbourne, Florida, 32901
Pfizer Investigational Site
Milwaukee, Wisconsin, 53209
Pfizer Investigational Site
Mount Vernon, New York, 10550
Pfizer Investigational Site
Newport News, Virginia, 23606
Pfizer Investigational Site
Oklahoma City, Oklahoma, 73103
Pfizer Investigational Site
Omaha, Nebraska, 68131
Pfizer Investigational Site
Richmond, Virginia, 23225
Pfizer Investigational Site
Richmond, Virginia, 23249
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
San Antonio, Texas, 78229
Pfizer Investigational Site
Springfield, Missouri, 65807
Pfizer Investigational Site
Tulsa, Oklahoma, 74136
Pfizer Investigational Site
Walnut Creek, California, 94598
Pfizer Investigational Site
Yakima, Washington, 98902
About this study
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
To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia and type 2 diabetes
- Conditions
- Dyslipidemia
- Being tested
- CP-778,875
- Medical subject headings
- Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CP-778,875Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
HDL-C Safety and Efficacy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2006 (estimated)
- Study startJul 2006
- Study completionJun 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DyslipidemiaStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 84 participants
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00326326
- Sponsor's protocol ID
- A5561005
- Status last verified
- May 2009
- First submitted
- 12 May 2006
- Last updated
- 7 May 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00326326
- Acronym / sponsor ID
- A5561005
- Conditions
- Dyslipidemia
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Jul 2006
- Study completion
- Jun 2007 (actual)
- First posted
- 16 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the effect of CP-778,875 on HDL-C cholesterol in adult subjects with dyslipidemia and type 2 diabetes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Known cardiovascular, carotid, or peripheral vascular disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CP-778,875 | Drug | – |
Primary outcome
HDL-C Safety and Efficacy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2009.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Related trials for Dyslipidemia
Active, not recruitingObservational study
Study Evaluating LDL-C Change and Adherence to Inclisiran Lipid-lowering Therapy in ASCVD
Primary Hypercholesterolemia, Mixed Dyslipidemia
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
31 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CP-778,875 in people with Dyslipidemia, run by Pfizer at 31 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDL-C Safety and Efficacy. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2009.