Dyslipidemia Clinical Trial
Official title:
A 30-Week, Multicenter, Randomized, Double-Blind, Parallel-Group Study of the Combination of ABT-335 and Rosuvastatin Compared to Rosuvastatin Monotherapy in Dyslipidemic Subjects With Stage 3 Chronic Kidney Disease
| 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 objective of this study is to evaluate the safety and efficacy of the combination of ABT-335 plus rosuvastatin in dyslipidemic subjects with Chronic Kidney Disease (CKD) Stage 3.
| Status | Completed |
| Enrollment | 280 |
| Est. completion date | April 2011 |
| Est. primary completion date | April 2011 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria - Dyslipidemic participants with Chronic Kidney Disease Stage 3 - For entry into the Treatment Phase (Visit 3), the participant satisfied the following laboratory criteria (measured at the Screening Visit[s]): - Estimated glomerular filtration rate between 30 and 59 mL/min/1.73 m2 (Chronic Kidney Disease Stage 3) by simplified 4 variable Modification of Diet in Renal Disease formula (this includes a 10 percent variation in the upper limit of estimated glomerular filtration rate that was allowed for the enrollment of participants to account for variability in the creatinine assay). - Fasting lipid results following greater than or equal to 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 Exclusion Criteria - Participants with certain chronic or unstable medical conditions. - Participants with unstable dose of medications or receiving coumarin anticoagulants, systemic cyclosporine, or certain other medications. - Pregnant or lactating women, or women intending to become pregnant. - Participants with diabetes mellitus that is poorly controlled. - Participants of Asian ancestry (having Filipino, Chinese, Japanese, Korean, Vietnamese, or Asian-Indian origin). |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Puerto Rico | Site Reference ID/Investigator# 24402 | Carolina | |
| Puerto Rico | Site Reference ID/Investigator# 22545 | Humacao | |
| Puerto Rico | Site Reference ID/Investigator# 8301 | Manati | |
| Puerto Rico | Site Reference ID/Investigator# 8299 | Ponce | |
| Puerto Rico | Site Reference ID/Investigator# 8418 | Ponce | |
| Puerto Rico | Site Reference ID/Investigator# 8419 | Ponce | |
| Puerto Rico | Site Reference ID/Investigator# 8300 | San Juan | |
| Puerto Rico | Site Reference ID/Investigator# 8421 | San Juan | |
| Puerto Rico | Site Reference ID/Investigator# 8422 | San Juan | |
| Puerto Rico | Site Reference ID/Investigator# 8423 | San Juan | |
| Puerto Rico | Site Reference ID/Investigator# 8420 | Toa Baja | |
| Puerto Rico | Site Reference ID/Investigator# 8298 | Yabucoa | |
| United States | Site Reference ID/Investigator# 7958 | Arvada | Colorado |
| United States | Site Reference ID/Investigator# 8136 | Atlanta | Georgia |
| United States | Site Reference ID/Investigator# 21805 | Auburn | Maine |
| United States | Site Reference ID/Investigator# 38405 | Baton Rouge | Louisiana |
| United States | Site Reference ID/Investigator# 8345 | Bend | Oregon |
| United States | Site Reference ID/Investigator# 22703 | Berlin | New Jersey |
| United States | Site Reference ID/Investigator# 8411 | Bethlehem | Pennsylvania |
| United States | Site Reference ID/Investigator# 22521 | Birmingham | Alabama |
| United States | Site Reference ID/Investigator# 23224 | Boynton Beach | Florida |
| United States | Site Reference ID/Investigator# 22222 | Brooklyn Center | Minnesota |
| United States | Site Reference ID/Investigator# 8405 | Carlisle | Pennsylvania |
| United States | Site Reference ID/Investigator# 22823 | Charleston | South Carolina |
| United States | Site Reference ID/Investigator# 22481 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 22708 | Charlotte | North Carolina |
| United States | Site Reference ID/Investigator# 27682 | Chicago | Illinois |
| United States | Site Reference ID/Investigator# 7869 | Chula Vista | California |
| United States | Site Reference ID/Investigator# 8417 | Cincinnati | Ohio |
| United States | Site Reference ID/Investigator# 22474 | Clearwater | Florida |
| United States | Site Reference ID/Investigator# 8364 | Columbia | South Carolina |
| United States | Site Reference ID/Investigator# 8147 | Columbus | Ohio |
| United States | Site Reference ID/Investigator# 21803 | Coral Springs | Florida |
| United States | Site Reference ID/Investigator# 8094 | Council Bluffs | Iowa |
| United States | Site Reference ID/Investigator# 22812 | Dallas | Texas |
| United States | Site Reference ID/Investigator# 22811 | Daytona Beach | Florida |
| United States | Site Reference ID/Investigator# 15881 | Denver | Colorado |
| United States | Site Reference ID/Investigator# 22387 | Duncansville | Pennsylvania |
| United States | Site Reference ID/Investigator# 23503 | Dunwoody | Georgia |
| United States | Site Reference ID/Investigator# 8536 | Edinburg | Texas |
| United States | Site Reference ID/Investigator# 22707 | Elizabeth | New Jersey |
| United States | Site Reference ID/Investigator# 8225 | Fall River | Massachusetts |
| United States | Site Reference ID/Investigator# 8387 | Flushing | New York |
| United States | Site Reference ID/Investigator# 22810 | Fort Worth | Texas |
| United States | Site Reference ID/Investigator# 8435 | Fountain Valley | California |
| United States | Site Reference ID/Investigator# 8413 | Gig Harbor | Washington |
| United States | Site Reference ID/Investigator# 8177 | Great Neck | New York |
| United States | Site Reference ID/Investigator# 22429 | Greenville | South Carolina |
| United States | Site Reference ID/Investigator# 22702 | Hillsborough | New Jersey |
| United States | Site Reference ID/Investigator# 27103 | Hollywood | Florida |
| United States | Site Reference ID/Investigator# 24742 | Houston | Texas |
| United States | Site Reference ID/Investigator# 26722 | Houston | Texas |
| United States | Site Reference ID/Investigator# 8406 | Houston | Texas |
| United States | Site Reference ID/Investigator# 8398 | Hudson | Florida |
| United States | Site Reference ID/Investigator# 22478 | Huntsville | Alabama |
| United States | Site Reference ID/Investigator# 22430 | Iowa City | Iowa |
| United States | Site Reference ID/Investigator# 22815 | Jersey Shore | Pennsylvania |
| United States | Site Reference ID/Investigator# 12881 | Johnstown | Pennsylvania |
| United States | Site Reference ID/Investigator# 26723 | Kissimmee | Florida |
| United States | Site Reference ID/Investigator# 37676 | Kissimmee | Florida |
| United States | Site Reference ID/Investigator# 8146 | Lake Success | New York |
| United States | Site Reference ID/Investigator# 8231 | Lauderdale Lakes | Florida |
| United States | Site Reference ID/Investigator# 22487 | Lincoln | California |
| United States | Site Reference ID/Investigator# 22426 | Long Beach | California |
| United States | Site Reference ID/Investigator# 22486 | Longwood | Florida |
| United States | Site Reference ID/Investigator# 8096 | Los Angeles | California |
| United States | Site Reference ID/Investigator# 8232 | Lubbock | Texas |
| United States | Site Reference ID/Investigator# 7948 | Macon | Georgia |
| United States | Site Reference ID/Investigator# 8365 | Madison | Alabama |
| United States | Site Reference ID/Investigator# 22488 | Mason | Ohio |
| United States | Site Reference ID/Investigator# 22704 | Medford | Oregon |
| United States | Site Reference ID/Investigator# 13922 | Mishawaka | Indiana |
| United States | Site Reference ID/Investigator# 8416 | Montgomery | Alabama |
| United States | Site Reference ID/Investigator# 8434 | Morehead City | North Carolina |
| United States | Site Reference ID/Investigator# 22428 | Mount Pleasant | South Carolina |
| United States | Site Reference ID/Investigator# 22520 | New Port Richey | Florida |
| United States | Site Reference ID/Investigator# 22962 | Norwalk | California |
| United States | Site Reference ID/Investigator# 21804 | Ogden | Utah |
| United States | Site Reference ID/Investigator# 22479 | Oklahoma City | Oklahoma |
| United States | Site Reference ID/Investigator# 23225 | Oklahoma City | Oklahoma |
| United States | Site Reference ID/Investigator# 8408 | Olive Branch | Mississippi |
| United States | Site Reference ID/Investigator# 8226 | Orlando | Florida |
| United States | Site Reference ID/Investigator# 22477 | Ormond Beach | Florida |
| United States | Site Reference ID/Investigator# 8093 | Paducah | Kentucky |
| United States | Site Reference ID/Investigator# 8386 | Pembroke Pines | Florida |
| United States | Site Reference ID/Investigator# 8227 | Peoria | Illinois |
| United States | Site Reference ID/Investigator# 22706 | Perkasie | Pennsylvania |
| United States | Site Reference ID/Investigator# 8095 | Philadelphia | Pennsylvania |
| United States | Site Reference ID/Investigator# 22518 | Plant City | Florida |
| United States | Site Reference ID/Investigator# 12882 | Port Charlotte | Florida |
| United States | Site Reference ID/Investigator# 8400 | Portland | Oregon |
| United States | Site Reference ID/Investigator# 8098 | Providence | Rhode Island |
| United States | Site Reference ID/Investigator# 8311 | Riverside | California |
| United States | Site Reference ID/Investigator# 8092 | Rockville | Maryland |
| United States | Site Reference ID/Investigator# 22819 | Roswell | Georgia |
| United States | Site Reference ID/Investigator# 8415 | Royal Oak | Michigan |
| United States | Site Reference ID/Investigator# 22816 | Sacramento | California |
| United States | Site Reference ID/Investigator# 22423 | Salt Lake City | Utah |
| United States | Site Reference ID/Investigator# 22480 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 8397 | San Antonio | Texas |
| United States | Site Reference ID/Investigator# 8903 | Shreveport | Louisiana |
| United States | Site Reference ID/Investigator# 8510 | Simi Valley | California |
| United States | Site Reference ID/Investigator# 8407 | Springfield | Massachusetts |
| United States | Site Reference ID/Investigator# 37675 | St. Cloud | Florida |
| United States | Site Reference ID/Investigator# 25302 | Summerville | South Carolina |
| United States | Site Reference ID/Investigator# 22813 | Suwanee | Georgia |
| United States | Site Reference ID/Investigator# 22705 | Tipton | Pennsylvania |
| United States | Site Reference ID/Investigator# 22482 | Tulsa | Oklahoma |
| United States | Site Reference ID/Investigator# 22817 | Warminster | Pennsylvania |
| United States | Site Reference ID/Investigator# 22821 | West Hills | California |
| United States | Site Reference ID/Investigator# 8410 | West Palm Beach | Florida |
| United States | Site Reference ID/Investigator# 8399 | Westminster | Colorado |
| United States | Site Reference ID/Investigator# 22427 | Williamsville | New York |
| United States | Site Reference ID/Investigator# 21802 | Winter Haven | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| AstraZeneca |
United States, Puerto Rico,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Median Percent Change in Triglycerides From Baseline to Week 8. | Triglycerides were measured in milligrams/deciliter. | Baseline to 8 weeks | No |
| Secondary | Mean Percent Change in High-Density Lipoprotein Cholesterol From Baseline to Week 8. | High-density lipoprotein cholesterol (HDL-C) was measured in milligrams/deciliter (mg/dL). | Baseline to 8 weeks | No |
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