Hypercholesterolemia Clinical Trial
Official title:
A 12-week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to ABT-335 and Rosuvastatin Monotherapy in Subjects With Type IIa and IIb Dyslipidemia
| Verified date | September 2012 |
| Source | AstraZeneca |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | United States: Food and Drug Administration |
| Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of ABT-335 and rosuvastatin calcium combination therapy to monotherapy in subjects with dyslipidemia.
| Status | Completed |
| Enrollment | 760 |
| Est. completion date | February 2008 |
| Est. primary completion date | February 2008 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria - Adult male and female participants who voluntarily sign the informed consent. - Fasting lipid results following greater than 12-hour fasting period: - Triglycerides level greater than or equal to 150 mg/dL, - High-density lipoprotein cholesterol less than 40 mg/dL for males and less than 50 mg/dL for females, and - Low-density lipoprotein cholesterol greater than or equal to 130 mg/dL. - Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet. Exclusion Criteria - Participants with unstable medical conditions, medical conditions considered inappropriate in a clinical trial, or participants who are taking excluded concomitant medications are not allowed in the study. - Participants receiving coumarin anticoagulants or systemic cyclosporine. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| United States | Site Reference ID/Investigator# 4427 | Albuquerque | New Mexico |
| United States | Site Reference ID/Investigator# 4702 | Anaheim | California |
| United States | Site Reference ID/Investigator# 5533 | Ann Arbor | Michigan |
| United States | Site Reference ID/Investigator# 6237 | Ann Arbor | Michigan |
| United States | Site Reference ID/Investigator# 4393 | Arkansas City | Kansas |
| United States | Site Reference ID/Investigator# 5454 | Arlington | Texas |
| United States | Site Reference ID/Investigator# 4472 | Arlington Heights | Illinois |
| United States | Site Reference ID/Investigator# 4473 | Asheville | North Carolina |
| United States | Site Reference ID/Investigator# 5635 | Auburn | Maine |
| United States | Site Reference ID/Investigator# 4442 | Aurora | Colorado |
| United States | Site Reference ID/Investigator# 4527 | Avon | Indiana |
| United States | Site Reference ID/Investigator# 5070 | Baltimore | Maryland |
| United States | Site Reference ID/Investigator# 4979 | Billings | Montana |
| United States | Site Reference ID/Investigator# 4428 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 4985 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 5469 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 5478 | Blue Ridge | Georgia |
| United States | Site Reference ID/Investigator# 4463 | Bronxville | New York |
| United States | Site Reference ID/Investigator# 4480 | Brooklyn Center | Minnesota |
| United States | Site Reference ID/Investigator# 4470 | Carlisle | Pennsylvania |
| United States | Site Reference ID/Investigator# 4395 | Chandler | Arizona |
| United States | Site Reference ID/Investigator# 4506 | Charleston | South Carolina |
| United States | Site Reference ID/Investigator# 4396 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 4531 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 5585 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 5593 | Chula Vista | California |
| United States | Site Reference ID/Investigator# 4390 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 4400 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 4501 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 4517 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 4419 | Colorado Springs | Colorado |
| United States | Site Reference ID/Investigator# 5584 | Columbus | Ohio |
| United States | Site Reference ID/Investigator# 4503 | Concord | California |
| United States | Site Reference ID/Investigator# 5444 | Concord | New Hampshire |
| United States | Site Reference ID/Investigator# 4401 | Coral Gables | Florida |
| United States | Site Reference ID/Investigator# 4388 | Decatur | Georgia |
| United States | Site Reference ID/Investigator# 5581 | Downingtown | Pennsylvania |
| United States | Site Reference ID/Investigator# 4511 | Dunwoody | Georgia |
| United States | Site Reference ID/Investigator# 4908 | Elizabeth | New Jersey |
| United States | Site Reference ID/Investigator# 4530 | Encinitas | California |
| United States | Site Reference ID/Investigator# 4485 | Evansville | Indiana |
| United States | Site Reference ID/Investigator# 4458 | Fair Oaks | California |
| United States | Site Reference ID/Investigator# 4456 | Falls Church | Virginia |
| United States | Site Reference ID/Investigator# 4434 | Feasterville | Pennsylvania |
| United States | Site Reference ID/Investigator# 4453 | Fort Lauderdale | Florida |
| United States | Site Reference ID/Investigator# 4542 | Fresno | California |
| United States | Site Reference ID/Investigator# 4574 | Fresno | California |
| United States | Site Reference ID/Investigator# 4483 | Gilbert | Arizona |
| United States | Site Reference ID/Investigator# 5443 | Greenville | South Carolina |
| United States | Site Reference ID/Investigator# 4484 | Greer | South Carolina |
| United States | Site Reference ID/Investigator# 4478 | Harleysville | Pennsylvania |
| United States | Site Reference ID/Investigator# 4412 | Haverhill | Massachusetts |
| United States | Site Reference ID/Investigator# 5494 | Hickory | North Carolina |
| United States | Site Reference ID/Investigator# 4490 | Holly Hill | Florida |
| United States | Site Reference ID/Investigator# 4420 | Hollywood | Florida |
| United States | Site Reference ID/Investigator# 5578 | Houston | Texas |
| United States | Site Reference ID/Investigator# 5669 | Houston | Texas |
| United States | Site Reference ID/Investigator# 4493 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 4510 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 4445 | Indianapolis | Indiana |
| United States | Site Reference ID/Investigator# 4403 | Iowa City | Iowa |
| United States | Site Reference ID/Investigator# 4435 | Jackson | Tennessee |
| United States | Site Reference ID/Investigator# 4515 | Jackson | Mississippi |
| United States | Site Reference ID/Investigator# 4444 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 5011 | Jacksonville | Florida |
| United States | Site Reference ID/Investigator# 4436 | Jersey Shore | Pennsylvania |
| United States | Site Reference ID/Investigator# 4454 | Johnson City | Tennessee |
| United States | Site Reference ID/Investigator# 4399 | Jupiter | Florida |
| United States | Site Reference ID/Investigator# 4500 | Kansas City | Missouri |
| United States | Site Reference ID/Investigator# 4433 | Kissimmee | Florida |
| United States | Site Reference ID/Investigator# 4438 | Lafayette | Indiana |
| United States | Site Reference ID/Investigator# 4421 | Lakewood | Washington |
| United States | Site Reference ID/Investigator# 4397 | Lansdale | Pennsylvania |
| United States | Site Reference ID/Investigator# 4469 | Largo | Florida |
| United States | Site Reference ID/Investigator# 4460 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 4466 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 5484 | Las Vegas | Nevada |
| United States | Site Reference ID/Investigator# 5027 | Lexington | Kentucky |
| United States | Site Reference ID/Investigator# 4441 | Lincoln | California |
| United States | Site Reference ID/Investigator# 4417 | Little Rock | Arkansas |
| United States | Site Reference ID/Investigator# 4432 | Long Beach | California |
| United States | Site Reference ID/Investigator# 5579 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 4471 | Louisville | Kentucky |
| United States | Site Reference ID/Investigator# 4468 | Madison | Wisconsin |
| United States | Site Reference ID/Investigator# 4467 | Medford | Oregon |
| United States | Site Reference ID/Investigator# 4525 | Melbourne | Florida |
| United States | Site Reference ID/Investigator# 4426 | Melrose Park | Pennsylvania |
| United States | Site Reference ID/Investigator# 4477 | Miami | Florida |
| United States | Site Reference ID/Investigator# 4481 | Missoula | Montana |
| United States | Site Reference ID/Investigator# 4410 | Mogadore | Ohio |
| United States | Site Reference ID/Investigator# 4455 | Moncks Corner | South Carolina |
| United States | Site Reference ID/Investigator# 4479 | Morehead City | North Carolina |
| United States | Site Reference ID/Investigator# 4513 | Mount Pleasant | South Carolina |
| United States | Site Reference ID/Investigator# 4529 | Nashville | Tennessee |
| United States | Site Reference ID/Investigator# 4406 | New Orleans | Louisiana |
| United States | Site Reference ID/Investigator# 4430 | New Port Richey | Florida |
| United States | Site Reference ID/Investigator# 4409 | New Smyrna Beach | Florida |
| United States | Site Reference ID/Investigator# 4415 | New York | New York |
| United States | Site Reference ID/Investigator# 5010 | Newburgh | Indiana |
| United States | Site Reference ID/Investigator# 4894 | Newtown | Pennsylvania |
| United States | Site Reference ID/Investigator# 4980 | Norwalk | California |
| United States | Site Reference ID/Investigator# 4416 | Ocala | Florida |
| United States | Site Reference ID/Investigator# 4528 | Ocala | Florida |
| United States | Site Reference ID/Investigator# 4451 | Oklahoma City | Oklahoma |
| United States | Site Reference ID/Investigator# 4488 | Oklahoma City | Oklahoma |
| United States | Site Reference ID/Investigator# 4492 | Olive Branch | Mississippi |
| United States | Site Reference ID/Investigator# 5103 | Orlando | Florida |
| United States | Site Reference ID/Investigator# 4446 | Ormond Beach | Florida |
| United States | Site Reference ID/Investigator# 4526 | Overland Park | Kansas |
| United States | Site Reference ID/Investigator# 4431 | Ozark | Alabama |
| United States | Site Reference ID/Investigator# 4496 | Penndel | Pennsylvania |
| United States | Site Reference ID/Investigator# 4524 | Pensacola | Florida |
| United States | Site Reference ID/Investigator# 4520 | Peoria | Illinois |
| United States | Site Reference ID/Investigator# 4387 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 4404 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 4437 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 5583 | Portage | Michigan |
| United States | Site Reference ID/Investigator# 4461 | Raleigh | North Carolina |
| United States | Site Reference ID/Investigator# 4408 | Richmond | Virginia |
| United States | Site Reference ID/Investigator# 4459 | Richmond | Virginia |
| United States | Site Reference ID/Investigator# 4440 | Rochester | New York |
| United States | Site Reference ID/Investigator# 4448 | Roswell | Georgia |
| United States | Site Reference ID/Investigator# 4981 | Roswell | Georgia |
| United States | Site Reference ID/Investigator# 4392 | Sacramento | California |
| United States | Site Reference ID/Investigator# 4896 | Sacramento | California |
| United States | Site Reference ID/Investigator# 4498 | Salisbury | North Carolina |
| United States | Site Reference ID/Investigator# 4429 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 4457 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 4465 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 4508 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 4892 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 4893 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 5948 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 5582 | San Diego | California |
| United States | Site Reference ID/Investigator# 4443 | Sandusky | Ohio |
| United States | Site Reference ID/Investigator# 4505 | Sarasota | Florida |
| United States | Site Reference ID/Investigator# 5580 | Sarasota | Florida |
| United States | Site Reference ID/Investigator# 4502 | Scarborough | Maine |
| United States | Site Reference ID/Investigator# 4411 | Scottsdale | Arizona |
| United States | Site Reference ID/Investigator# 4521 | Simpsonville | South Carolina |
| United States | Site Reference ID/Investigator# 5586 | Sioux Falls | South Dakota |
| United States | Site Reference ID/Investigator# 4509 | Slidell | Louisiana |
| United States | Site Reference ID/Investigator# 4504 | South Bound Brook | New Jersey |
| United States | Site Reference ID/Investigator# 4487 | Springfield | Massachusetts |
| United States | Site Reference ID/Investigator# 4499 | St. Peters | Missouri |
| United States | Site Reference ID/Investigator# 4405 | Statesville | North Carolina |
| United States | Site Reference ID/Investigator# 4982 | Summerville | South Carolina |
| United States | Site Reference ID/Investigator# 4497 | Suwanee | Georgia |
| United States | Site Reference ID/Investigator# 4464 | Syracuse | New York |
| United States | Site Reference ID/Investigator# 4413 | Temple | Texas |
| United States | Site Reference ID/Investigator# 4394 | Toms River | New Jersey |
| United States | Site Reference ID/Investigator# 4402 | Trenton | New Jersey |
| United States | Site Reference ID/Investigator# 4422 | Tulsa | Oklahoma |
| United States | Site Reference ID/Investigator# 4482 | Tulsa | Oklahoma |
| United States | Site Reference ID/Investigator# 5636 | Tupelo | Mississippi |
| United States | Site Reference ID/Investigator# 4519 | Tuscaloosa | Alabama |
| United States | Site Reference ID/Investigator# 4447 | Warminster | Pennsylvania |
| United States | Site Reference ID/Investigator# 4523 | Warren | Ohio |
| United States | Site Reference ID/Investigator# 4391 | Waterbury | Connecticut |
| United States | Site Reference ID/Investigator# 6236 | West Hills | California |
| United States | Site Reference ID/Investigator# 4407 | West Palm Beach | Florida |
| United States | Site Reference ID/Investigator# 4494 | West Palm Beach | Florida |
| United States | Site Reference ID/Investigator# 4423 | Wichita | Kansas |
| United States | Site Reference ID/Investigator# 4424 | Wichita | Kansas |
| United States | Site Reference ID/Investigator# 4425 | Williamsville | New York |
| United States | Site Reference ID/Investigator# 4476 | Winston-Salem | North Carolina |
| United States | Site Reference ID/Investigator# 4512 | Winter Haven | Florida |
| United States | Site Reference ID/Investigator# 4439 | Woodstock | Georgia |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean Percent Change From Baseline to the Final Visit in High-density Lipoprotein Cholesterol (HDL-C) (Full Analysis Set) | The mean percent change from baseline to the final visit in High-density lipoprotein cholesterol (HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | No |
| Primary | Mean Percent Change From Baseline to the Final Visit in Triglycerides (Full Analysis Set) | The mean percent change from baseline to the final visit in triglycerides, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | No |
| Primary | Mean Percent Change From Baseline to the Final Visit in Low-density Lipoprotein Cholesterol (LDL-C) (Full Analysis Set) | The mean percent change from baseline to the final visit in low-density lipoprotein cholesterol (LDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. | Baseline to 12 Weeks | No |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus ABT-335 135 mg Monotherapy (Full Analysis Set) | The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus ABT-335 135 mg monotherapy. | Baseline to 12 Weeks | No |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Non-high-density Lipoprotein Cholesterol (Non-HDL-C), With ABT-335 135 mg in Combination With Rosuvastatin 5 mg Versus Rosuvastatin 5 mg Monotherapy (Full Analysis Set) | The mean percent change from baseline to the final visit in non-high-density lipoprotein cholesterol (non-HDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | No |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Very-low-density Lipoprotein Cholesterol (VLDL-C) (Full Analysis Set) | The mean percent change from baseline to the final visit in very-low-density lipoprotein cholesterol (VLDL-C), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | No |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Apolipoprotein B (ApoB) (Full Analysis Set) | The mean percent change from baseline to the final visit in apolipoprotein B (ApoB), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | No |
| Secondary | Median Percent Change From Baseline to the Final Visit in High Sensitivity C-reactive Protein (hsCRP) (Full Analysis Set) | The median percent change from baseline to the final visit in high sensitivity C-reactive protein (hsCRP), with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | No |
| Secondary | Mean Percent Change From Baseline to the Final Visit in Total Cholesterol (Full Analysis Set) | The mean percent change from baseline to the final visit in total cholesterol, with ABT-335 135 mg in combination with rosuvastatin 5 mg versus rosuvastatin 5 mg monotherapy. | Baseline to 12 Weeks | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT04998695 -
Health Effects of Consuming Olive Pomace Oil
|
N/A | |
| Recruiting |
NCT03947866 -
Ezetimibe-Rosuvastatin Evaluation Study
|
||
| Completed |
NCT01709513 -
Study of Alirocumab (REGN727/SAR236553) in Patients With Primary Hypercholesterolemia and Moderate, High, or Very High Cardiovascular (CV) Risk, Who Are Intolerant to Statins (ODYSSEY ALTERNATIVE)
|
Phase 3 | |
| Completed |
NCT01212900 -
Randomized Trial of Imaging Versus Risk Factor-Based Therapy for Plaque Regression
|
Phase 4 | |
| Completed |
NCT00001154 -
Lipoprotein Metabolism in Normal Volunteers and Patients With High Levels of Lipoproteins
|
||
| Completed |
NCT02550288 -
A Clinical Trial to Assess the Efficacy and Safety of MK-0653C in Japanese Participants With Hypercholesterolemia (MK-0653C-383)
|
Phase 3 | |
| Completed |
NCT03929198 -
Translation of Pritikin Program to the Community
|
N/A | |
| Completed |
NCT04485793 -
Effect of a Dietary Supplement on Lipid Pattern and Liver Parameters in Hypercholesterolemia
|
N/A | |
| Completed |
NCT02341924 -
Validating the "Foods for Health" Portfolio of Functional Food Products
|
N/A | |
| Active, not recruiting |
NCT02223793 -
Vascular Lifestyle-Intervention and Screening in Pharmacy
|
N/A | |
| Completed |
NCT01941836 -
Evaluation of ETC-1002, Ezetimibe, and the Combination in Hypercholesterolemic Patients
|
Phase 2 | |
| Completed |
NCT01934608 -
The Effect of Synching Prescription Refills on Adherence
|
N/A | |
| Recruiting |
NCT01705873 -
Analysis on the Risk of Cardiovascular Events in HIV- Infected Subjects Treated With LPV/r Based HAART Regimen vs. an EFV Based Regimen
|
N/A | |
| Completed |
NCT01678521 -
Effect of LDL-apheresis on PTX3 Plasma Levels in Hypercholesterolemic Patients
|
N/A | |
| Completed |
NCT01670734 -
Pharmacokinetic and Tolerability of Alirocumab SAR236553 (REGN727) in Patients With Hepatic Impairment and in Healthy Subjects
|
Phase 1 | |
| Completed |
NCT01370603 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/40 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 40 mg Tablets in Participants With High Cholesterol (MK-0653C-190 AM1)
|
Phase 3 | |
| Completed |
NCT01370590 -
A Study to Evaluate the Effectiveness of Ezetimibe/Atorvastatin 10 mg/20 mg Combination Tablet Compared to Marketed Ezetimibe 10 mg and Atorvastatin 20 mg Tablets in Participants With High Cholesterol (MK-0653C-185 AM1)
|
Phase 3 | |
| Completed |
NCT01575171 -
Using Nudges to Implement Comparative Effectiveness
|
N/A | |
| Completed |
NCT01478789 -
Efficacy of Plant Sterol-Fortified Dairy Product on Plasma Lipid and Plant Sterol Concentrations in Humans
|
N/A | |
| Completed |
NCT01768403 -
Centralised Pan-Algerian Survey on the Undertreatment of Hypercholesterolemia
|
N/A |