Hyperlipidemia Clinical Trial
Official title:
Phase 3, Multi-Center, Double-Blind, Randomized, Parallel Group, Study of the Efficacy, Safety, and Tolerability of Fixed Combination Torcetrapib (CP-529,414) / Atorvastatin Administered Orally, Once Daily (QD) for Six Months, Compared With Maximally Tolerated Atorvastatin Therapy Alone, in Subjects With Heterozygous Familial Hypercholesterolemia
Verified date | December 2006 |
Source | Pfizer |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
The Torcetrapib project was terminated on December 2, 2006 due to safety findings.
To evaluate the efficacy and safety of torcetrapib/atorvastatin compared to atorvastatin
alone in patients with heterozygous familial hypercholesterolemia
Status | Completed |
Enrollment | 400 |
Est. completion date | March 2006 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosis of Heterozygous Familial Hypercholesterolemia - At least 18 years of age Exclusion Criteria: - Women who are pregnant or lactating, or planning to become pregnant. - Subjects with a clinically indicated need for statin (HMG-CoA reductase inhibitor) therapy other than atorvastatin or other concomitant therapy with known lipid altering effects on LDL-C and HDL-C including fibrates and nicotinic acid (high doses) - Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG-CoA reductase inhibitors - Subjects with any other medical condition or laboratory abnormality which could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Australia | Pfizer Investigational Site | Camperdown | New South Wales |
Australia | Pfizer Investigational Site | Clayton | Victoria |
Australia | Pfizer Investigational Site | Darlinghurst | |
Australia | Pfizer Investigational Site | North Adelaide | South Australia |
Australia | Pfizer Investigational Site | Perth | Western Australia |
Australia | Pfizer Investigational Site | Woolloongabba | Queensland |
Canada | Pfizer Investigational Site | Chicoutimi | Quebec |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Montreal | Quebec |
Canada | Pfizer Investigational Site | Ste-Foy | Quebec |
Denmark | Pfizer Investigational Site | Aalborg | |
Denmark | Pfizer Investigational Site | Arhus C | |
France | Pfizer Investigational Site | Dijon | |
France | Pfizer Investigational Site | Nantes cedex 01 | |
France | Pfizer Investigational Site | Paris | |
France | Pfizer Investigational Site | Unknown | Lille |
Iceland | Pfizer Investigational Site | Kopavogur | |
Norway | Pfizer Investigational Site | Oslo | |
Norway | Pfizer Investigational Site | Oslo | |
South Africa | Pfizer Investigational Site | Bellville | Western Cape |
South Africa | Pfizer Investigational Site | Bloemfontein | |
South Africa | Pfizer Investigational Site | Cape Town | |
South Africa | Pfizer Investigational Site | Parow | Cape Town |
Sweden | Pfizer Investigational Site | Goteborg | |
Sweden | Pfizer Investigational Site | Linkoping | |
Sweden | Pfizer Investigational Site | Malmo | |
Sweden | Pfizer Investigational Site | Stockholm | |
United States | Pfizer Investigational Site | Auburn | Maine |
United States | Pfizer Investigational Site | Boston | Massachusetts |
United States | Pfizer Investigational Site | Charlotte | North Carolina |
United States | Pfizer Investigational Site | Chicago | Illinois |
United States | Pfizer Investigational Site | Houston | Texas |
United States | Pfizer Investigational Site | Indianapolis | Indiana |
United States | Pfizer Investigational Site | Iowa City | Iowa |
United States | Pfizer Investigational Site | Lutz | Florida |
United States | Pfizer Investigational Site | Madison | Wisconsin |
United States | Pfizer Investigational Site | San Diego | California |
United States | Pfizer Investigational Site | Scarborough | Maine |
United States | Pfizer Investigational Site | Tampa | Florida |
United States | Pfizer Investigational Site | Tripler AMC | Hawaii |
United States | Pfizer Investigational Site | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Pfizer |
United States, Australia, Canada, Denmark, France, Iceland, Norway, South Africa, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in HDL-C and LDL-C | |||
Secondary | Changes in other lipid parameters |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
Completed |
NCT02927184 -
Safety and Tolerability of VK2809 in Patients With Primary Hypercholesterolemia and Non-Alcoholic Fatty Liver Disease
|
Phase 2 | |
Completed |
NCT04640012 -
Ascending-Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics of DC371739 Single-Dose Treatment in Healthy Subjects
|
Phase 1 | |
Completed |
NCT03213288 -
Bilberry Fruit and Black Rice Derived Anthocyanins on Lipid Status
|
N/A | |
Completed |
NCT00382564 -
Magnetic Resonance Angiography to Diagnose Atherosclerotic Disease
|
N/A | |
Recruiting |
NCT02979704 -
A Comparative Study of Rosuvastatin and Atorvastatin in Patients With Hyperlipidemia
|
Phase 2/Phase 3 | |
Completed |
NCT02569814 -
A Study to Compare the Pharmacokinetics and Safety of a Fixed Dose Combination of Fimasartan/Amlodipine/Rosuvastatin
|
Phase 1 | |
Completed |
NCT02280590 -
Comparison of the Efficacy and Safety of Cresnon® and Crestor® in Patients With Hyperlipidemia
|
Phase 4 | |
Completed |
NCT02428998 -
Safety for 24 Weeks Intake of Korean Red Ginseng in Adults
|
N/A | |
Completed |
NCT01678183 -
Financial Incentives for Medication Adherence
|
N/A | |
Completed |
NCT01694446 -
Regulation of Intestinal and Hepatic Lipoprotein Production by Glucose and Fructose
|
N/A | |
Completed |
NCT01426412 -
A Study of LY3015014 in Healthy Participants With Elevated Low Density Lipoprotein Cholesterol
|
Phase 1 | |
Completed |
NCT01131832 -
Genetic Basis for Heterogeneity in Response of Plasma Lipids to Plant Sterols
|
Phase 4 | |
Completed |
NCT00534105 -
Lipid Metabolism in Gestational Diabetes
|
N/A | |
Completed |
NCT00758303 -
A Study to Evaluate the Lipid Regulating Effects of TRIA-662
|
Phase 2/Phase 3 | |
Recruiting |
NCT00408824 -
Investigation of Genetic Risk of Metabolic Syndrome in Company Employee (NGK Study)
|
N/A | |
Completed |
NCT00362206 -
Comparison of the Combination of Fenofibrate and Simvastatin Versus Pravastatin
|
Phase 3 | |
Terminated |
NCT00299169 -
Randomized Trial Comparing N of 1 Trials to Standard Practice to Improve Adherence to Statins in Patients With Diabetes
|
Phase 4 | |
Completed |
NCT00414986 -
Using Learning Teams for Reflective Adaptation for Diabetes and Depression
|
N/A | |
Completed |
NCT00701454 -
Survey of Thai-Muslim Health Status
|
N/A |