Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
There are 3 treatment groups in the study: ABT-335 135 mg in combination with rosuvastatin 5 mg, ABT-335 135 mg monotherapy, and rosuvastatin 5 mg monotherapy. The 3 primary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in HDL-C and TG comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and mean percent change in LDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy. The 6 secondary outcome measures only compare 2 of the treatment groups for each variable (mean percent change in Non-HDL-C comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to ABT-335 135 mg monotherapy, mean percent change in Non-HDL-C, VLDL-C, ApoB, and Total Cholesterol comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy, and median percent change in hsCRP comparing ABT-335 135 mg in combination with rosuvastatin 5 mg to rosuvastatin 5 mg monotherapy).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ABT-335 and Rosuvastatin Calcium | Experimental | ABT-335 135mg in combination with rosuvastatin calcium 5mg administered orally, once daily for 12 weeks |
|
| ABT-335 | Active Comparator | ABT-335 135mg monotherapy administered orally, once daily for 12 weeks |
|
| Rosuvastatin Calcium | Active Comparator | Rosuvastatin calcium 5mg monotherapy administered orally, once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ABT-335 and rosuvastatin calcium | Drug | ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Not provided
Inclusion Criteria
Adult male and female participants who voluntarily sign the informed consent.
Fasting lipid results following greater than 12-hour fasting period:
Participant must agree to utilize adequate birth control methods and adhere to the American Heart Association (AHA) diet.
Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Torbjörn Lundström, MD | AstraZeneca | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site Reference ID/Investigator# 5469 | Birmingham | Alabama | 35205 | United States | ||
| Site Reference ID/Investigator# 4428 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21174145 | Derived | Rosenson RS, Carlson DM, Kelly MT, Setze CM, Hirshberg B, Stolzenbach JC, Williams LA. Achievement of lipid targets with the combination of rosuvastatin and fenofibric Acid in patients with type 2 diabetes mellitus. Cardiovasc Drugs Ther. 2011 Feb;25(1):47-57. doi: 10.1007/s10557-010-6273-5. | |
| 20953684 | Derived |
Not provided
Not provided
A total of 168 study sites screened participants, wtih 144 of these sites randomizing participants.
760 participants were randomized at 144 sites in the United States, and 758 participants were treated between 07 June 2007 and 10 February 2008. Two participants were randomized but not treated: 1 was lost to follow-up and 1 was withdrawn at the investigator's discretion.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | ABT-335 and Rosuvastatin Calcium | ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks |
| FG001 | ABT-335 | ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| ABT-335 | Drug | ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks |
|
|
| rosuvastatin calcium | Drug | Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks |
|
|
| Baseline to 12 Weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Birmingham |
| Alabama |
| 35209-6802 |
| United States |
| Site Reference ID/Investigator# 4985 | Birmingham | Alabama | 35235 | United States |
| Site Reference ID/Investigator# 4493 | Huntsville | Alabama | 35801 | United States |
| Site Reference ID/Investigator# 4510 | Huntsville | Alabama | 35802 | United States |
| Site Reference ID/Investigator# 4431 | Ozark | Alabama | 36360 | United States |
| Site Reference ID/Investigator# 4519 | Tuscaloosa | Alabama | 35406 | United States |
| Site Reference ID/Investigator# 4395 | Chandler | Arizona | 85225 | United States |
| Site Reference ID/Investigator# 4483 | Gilbert | Arizona | 85295 | United States |
| Site Reference ID/Investigator# 4411 | Scottsdale | Arizona | 85251 | United States |
| Site Reference ID/Investigator# 4417 | Little Rock | Arkansas | 72204 | United States |
| Site Reference ID/Investigator# 4702 | Anaheim | California | 92804 | United States |
| Site Reference ID/Investigator# 5593 | Chula Vista | California | 91911 | United States |
| Site Reference ID/Investigator# 4503 | Concord | California | 94520 | United States |
| Site Reference ID/Investigator# 4530 | Encinitas | California | 92024 | United States |
| Site Reference ID/Investigator# 4458 | Fair Oaks | California | 95628 | United States |
| Site Reference ID/Investigator# 4542 | Fresno | California | 93703 | United States |
| Site Reference ID/Investigator# 4574 | Fresno | California | 93710 | United States |
| Site Reference ID/Investigator# 4441 | Lincoln | California | 95648 | United States |
| Site Reference ID/Investigator# 4432 | Long Beach | California | 90806 | United States |
| Site Reference ID/Investigator# 5579 | Los Angeles | California | 90057 | United States |
| Site Reference ID/Investigator# 4980 | Norwalk | California | 90650 | United States |
| Site Reference ID/Investigator# 4392 | Sacramento | California | 95825 | United States |
| Site Reference ID/Investigator# 4896 | Sacramento | California | 95825 | United States |
| Site Reference ID/Investigator# 5582 | San Diego | California | 92128 | United States |
| Site Reference ID/Investigator# 6236 | West Hills | California | 91307 | United States |
| Site Reference ID/Investigator# 4442 | Aurora | Colorado | 80012 | United States |
| Site Reference ID/Investigator# 4419 | Colorado Springs | Colorado | 80909 | United States |
| Site Reference ID/Investigator# 4391 | Waterbury | Connecticut | 06708 | United States |
| Site Reference ID/Investigator# 4401 | Coral Gables | Florida | 33134 | United States |
| Site Reference ID/Investigator# 4453 | Fort Lauderdale | Florida | 33308 | United States |
| Site Reference ID/Investigator# 4490 | Holly Hill | Florida | 32117 | United States |
| Site Reference ID/Investigator# 4420 | Hollywood | Florida | 33021 | United States |
| Site Reference ID/Investigator# 5011 | Jacksonville | Florida | 32216 | United States |
| Site Reference ID/Investigator# 4444 | Jacksonville | Florida | 32259 | United States |
| Site Reference ID/Investigator# 4399 | Jupiter | Florida | 33458-7200 | United States |
| Site Reference ID/Investigator# 4433 | Kissimmee | Florida | 34741 | United States |
| Site Reference ID/Investigator# 4469 | Largo | Florida | 33773 | United States |
| Site Reference ID/Investigator# 4525 | Melbourne | Florida | 32935 | United States |
| Site Reference ID/Investigator# 4477 | Miami | Florida | 33173 | United States |
| Site Reference ID/Investigator# 4430 | New Port Richey | Florida | 34652 | United States |
| Site Reference ID/Investigator# 4409 | New Smyrna Beach | Florida | 32168 | United States |
| Site Reference ID/Investigator# 4416 | Ocala | Florida | 34471 | United States |
| Site Reference ID/Investigator# 4528 | Ocala | Florida | 34471 | United States |
| Site Reference ID/Investigator# 5103 | Orlando | Florida | 32806 | United States |
| Site Reference ID/Investigator# 4446 | Ormond Beach | Florida | 32174 | United States |
| Site Reference ID/Investigator# 4524 | Pensacola | Florida | 32514 | United States |
| Site Reference ID/Investigator# 4505 | Sarasota | Florida | 34233 | United States |
| Site Reference ID/Investigator# 5580 | Sarasota | Florida | 34239 | United States |
| Site Reference ID/Investigator# 4494 | West Palm Beach | Florida | 33401 | United States |
| Site Reference ID/Investigator# 4407 | West Palm Beach | Florida | 33407 | United States |
| Site Reference ID/Investigator# 4512 | Winter Haven | Florida | 33880 | United States |
| Site Reference ID/Investigator# 5478 | Blue Ridge | Georgia | 30513 | United States |
| Site Reference ID/Investigator# 4388 | Decatur | Georgia | 30033 | United States |
| Site Reference ID/Investigator# 4511 | Dunwoody | Georgia | 30338 | United States |
| Site Reference ID/Investigator# 4981 | Roswell | Georgia | 30075 | United States |
| Site Reference ID/Investigator# 4448 | Roswell | Georgia | 30076 | United States |
| Site Reference ID/Investigator# 4497 | Suwanee | Georgia | 30024 | United States |
| Site Reference ID/Investigator# 4439 | Woodstock | Georgia | 30189 | United States |
| Site Reference ID/Investigator# 4472 | Arlington Heights | Illinois | 60004 | United States |
| Site Reference ID/Investigator# 5585 | Chicago | Illinois | 60654 | United States |
| Site Reference ID/Investigator# 4520 | Peoria | Illinois | 61602 | United States |
| Site Reference ID/Investigator# 4527 | Avon | Indiana | 46123 | United States |
| Site Reference ID/Investigator# 4485 | Evansville | Indiana | 47714 | United States |
| Site Reference ID/Investigator# 4445 | Indianapolis | Indiana | 46260 | United States |
| Site Reference ID/Investigator# 4438 | Lafayette | Indiana | 47904 | United States |
| Site Reference ID/Investigator# 5010 | Newburgh | Indiana | 47630 | United States |
| Site Reference ID/Investigator# 4403 | Iowa City | Iowa | 52242 | United States |
| Site Reference ID/Investigator# 4393 | Arkansas City | Kansas | 67005 | United States |
| Site Reference ID/Investigator# 4526 | Overland Park | Kansas | 66202 | United States |
| Site Reference ID/Investigator# 4423 | Wichita | Kansas | 67203 | United States |
| Site Reference ID/Investigator# 4424 | Wichita | Kansas | 67207 | United States |
| Site Reference ID/Investigator# 5027 | Lexington | Kentucky | 40509 | United States |
| Site Reference ID/Investigator# 4471 | Louisville | Kentucky | 40213 | United States |
| Site Reference ID/Investigator# 4406 | New Orleans | Louisiana | 70112 | United States |
| Site Reference ID/Investigator# 4509 | Slidell | Louisiana | 70458 | United States |
| Site Reference ID/Investigator# 5635 | Auburn | Maine | 04210 | United States |
| Site Reference ID/Investigator# 4502 | Scarborough | Maine | 04074 | United States |
| Site Reference ID/Investigator# 5070 | Baltimore | Maryland | 21209 | United States |
| Site Reference ID/Investigator# 4412 | Haverhill | Massachusetts | 01830 | United States |
| Site Reference ID/Investigator# 4487 | Springfield | Massachusetts | 01103 | United States |
| Site Reference ID/Investigator# 5533 | Ann Arbor | Michigan | 48106 | United States |
| Site Reference ID/Investigator# 6237 | Ann Arbor | Michigan | 48106 | United States |
| Site Reference ID/Investigator# 5583 | Portage | Michigan | 49024 | United States |
| Site Reference ID/Investigator# 4480 | Brooklyn Center | Minnesota | 55430 | United States |
| Site Reference ID/Investigator# 4515 | Jackson | Mississippi | 39202 | United States |
| Site Reference ID/Investigator# 4492 | Olive Branch | Mississippi | 38654 | United States |
| Site Reference ID/Investigator# 5636 | Tupelo | Mississippi | 38801 | United States |
| Site Reference ID/Investigator# 4499 | City of Saint Peters | Missouri | 63376 | United States |
| Site Reference ID/Investigator# 4500 | Kansas City | Missouri | 64114 | United States |
| Site Reference ID/Investigator# 4979 | Billings | Montana | 59101 | United States |
| Site Reference ID/Investigator# 4481 | Missoula | Montana | 59808 | United States |
| Site Reference ID/Investigator# 4460 | Las Vegas | Nevada | 89102 | United States |
| Site Reference ID/Investigator# 4466 | Las Vegas | Nevada | 89123 | United States |
| Site Reference ID/Investigator# 5484 | Las Vegas | Nevada | 89146 | United States |
| Site Reference ID/Investigator# 5444 | Concord | New Hampshire | 03301 | United States |
| Site Reference ID/Investigator# 4908 | Elizabeth | New Jersey | 07202 | United States |
| Site Reference ID/Investigator# 4504 | South Bound Brook | New Jersey | 08880 | United States |
| Site Reference ID/Investigator# 4394 | Toms River | New Jersey | 08755 | United States |
| Site Reference ID/Investigator# 4402 | Trenton | New Jersey | 08611 | United States |
| Site Reference ID/Investigator# 4427 | Albuquerque | New Mexico | 87108 | United States |
| Site Reference ID/Investigator# 4463 | Bronxville | New York | 10708 | United States |
| Site Reference ID/Investigator# 4415 | New York | New York | 10021 | United States |
| Site Reference ID/Investigator# 4440 | Rochester | New York | 14609 | United States |
| Site Reference ID/Investigator# 4464 | Syracuse | New York | 13202 | United States |
| Site Reference ID/Investigator# 4425 | Williamsville | New York | 14221 | United States |
| Site Reference ID/Investigator# 4473 | Asheville | North Carolina | 28803 | United States |
| Site Reference ID/Investigator# 4531 | Charlotte | North Carolina | 28209 | United States |
| Site Reference ID/Investigator# 4396 | Charlotte | North Carolina | 28277 | United States |
| Site Reference ID/Investigator# 5494 | Hickory | North Carolina | 28601 | United States |
| Site Reference ID/Investigator# 4479 | Morehead City | North Carolina | 28557 | United States |
| Site Reference ID/Investigator# 4461 | Raleigh | North Carolina | 27609 | United States |
| Site Reference ID/Investigator# 4498 | Salisbury | North Carolina | 28144 | United States |
| Site Reference ID/Investigator# 4405 | Statesville | North Carolina | 28677 | United States |
| Site Reference ID/Investigator# 4476 | Winston-Salem | North Carolina | 27103 | United States |
| Site Reference ID/Investigator# 4390 | Cincinnati | Ohio | 45212 | United States |
| Site Reference ID/Investigator# 4400 | Cincinnati | Ohio | 45219 | United States |
| Site Reference ID/Investigator# 4501 | Cincinnati | Ohio | 45219 | United States |
| Site Reference ID/Investigator# 4517 | Cincinnati | Ohio | 45246 | United States |
| Site Reference ID/Investigator# 5584 | Columbus | Ohio | 43212 | United States |
| Site Reference ID/Investigator# 4410 | Mogadore | Ohio | 44260 | United States |
| Site Reference ID/Investigator# 4443 | Sandusky | Ohio | 44870 | United States |
| Site Reference ID/Investigator# 4523 | Warren | Ohio | 44483 | United States |
| Site Reference ID/Investigator# 4488 | Oklahoma City | Oklahoma | 73103 | United States |
| Site Reference ID/Investigator# 4451 | Oklahoma City | Oklahoma | 73112 | United States |
| Site Reference ID/Investigator# 4422 | Tulsa | Oklahoma | 74104 | United States |
| Site Reference ID/Investigator# 4482 | Tulsa | Oklahoma | 74136 | United States |
| Site Reference ID/Investigator# 4467 | Medford | Oregon | 97504 | United States |
| Site Reference ID/Investigator# 4470 | Carlisle | Pennsylvania | 17015 | United States |
| Site Reference ID/Investigator# 5581 | Downingtown | Pennsylvania | 19335 | United States |
| Site Reference ID/Investigator# 4434 | Feasterville | Pennsylvania | 19053 | United States |
| Site Reference ID/Investigator# 4478 | Harleysville | Pennsylvania | 19438-2513 | United States |
| Site Reference ID/Investigator# 4436 | Jersey Shore | Pennsylvania | 17740 | United States |
| Site Reference ID/Investigator# 4397 | Lansdale | Pennsylvania | 19046 | United States |
| Site Reference ID/Investigator# 4426 | Melrose Park | Pennsylvania | 19027 | United States |
| Site Reference ID/Investigator# 4894 | Newtown | Pennsylvania | 18940 | United States |
| Site Reference ID/Investigator# 4496 | Penndel | Pennsylvania | 19047 | United States |
| Site Reference ID/Investigator# 4404 | Philadelphia | Pennsylvania | 19114 | United States |
| Site Reference ID/Investigator# 4437 | Philadelphia | Pennsylvania | 19115 | United States |
| Site Reference ID/Investigator# 4387 | Philadelphia | Pennsylvania | 19152 | United States |
| Site Reference ID/Investigator# 4447 | Warminster | Pennsylvania | 18974 | United States |
| Site Reference ID/Investigator# 4506 | Charleston | South Carolina | 29407 | United States |
| Site Reference ID/Investigator# 5443 | Greenville | South Carolina | 29615 | United States |
| Site Reference ID/Investigator# 4484 | Greer | South Carolina | 29651 | United States |
| Site Reference ID/Investigator# 4455 | Moncks Corner | South Carolina | 29461 | United States |
| Site Reference ID/Investigator# 4513 | Mt. Pleasant | South Carolina | 29464 | United States |
| Site Reference ID/Investigator# 4521 | Simpsonville | South Carolina | 29681 | United States |
| Site Reference ID/Investigator# 4982 | Summerville | South Carolina | 29485 | United States |
| Site Reference ID/Investigator# 5586 | Sioux Falls | South Dakota | 57104 | United States |
| Site Reference ID/Investigator# 4435 | Jackson | Tennessee | 38305 | United States |
| Site Reference ID/Investigator# 4454 | Johnson City | Tennessee | 37601 | United States |
| Site Reference ID/Investigator# 4529 | Nashville | Tennessee | 37205 | United States |
| Site Reference ID/Investigator# 5454 | Arlington | Texas | 76012 | United States |
| Site Reference ID/Investigator# 5578 | Houston | Texas | 77030 | United States |
| Site Reference ID/Investigator# 5669 | Houston | Texas | 77030 | United States |
| Site Reference ID/Investigator# 4893 | San Antonio | Texas | 78205 | United States |
| Site Reference ID/Investigator# 4429 | San Antonio | Texas | 78215 | United States |
| Site Reference ID/Investigator# 4457 | San Antonio | Texas | 78224 | United States |
| Site Reference ID/Investigator# 4465 | San Antonio | Texas | 78229-4801 | United States |
| Site Reference ID/Investigator# 4508 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 4892 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 5948 | San Antonio | Texas | 78229 | United States |
| Site Reference ID/Investigator# 4413 | Temple | Texas | 76502 | United States |
| Site Reference ID/Investigator# 4456 | Falls Church | Virginia | 22044 | United States |
| Site Reference ID/Investigator# 4459 | Richmond | Virginia | 23226 | United States |
| Site Reference ID/Investigator# 4408 | Richmond | Virginia | 23294 | United States |
| Site Reference ID/Investigator# 4421 | Lakewood | Washington | 98499 | United States |
| Site Reference ID/Investigator# 4468 | Madison | Wisconsin | 53719 | United States |
| Roth EM, Rosenson RS, Carlson DM, Fukumoto SM, Setze CM, Blasetto JW, Khurmi NS, Stolzenbach JC, Williams LA. Efficacy and safety of rosuvastatin 5 mg in combination with fenofibric acid 135 mg in patients with mixed dyslipidemia - a phase 3 study. Cardiovasc Drugs Ther. 2010 Dec;24(5-6):421-8. doi: 10.1007/s10557-010-6266-4. |
| FG002 | Rosuvastatin Calcium | Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABT-335 and Rosuvastatin Calcium | ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks |
| BG001 | ABT-335 | ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks |
| BG002 | Rosuvastatin Calcium | Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline and at least 1 post-baseline value for high-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
|
| ||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for triglycerides. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for low-density lipoprotein cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for non-HDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for VLDL-C. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for ApoB. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for hsCRP. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Median | Inter-Quartile Range | percent change | Baseline to 12 Weeks |
|
| |||||||||||||||||||||||||||||
| 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. | Full Analysis Set was used and was defined as all randomized participants who had both a baseline value and at least 1 post-baseline value for total cholesterol. Last observation carried forward (LOCF) was used to impute values for participants missing a post-baseline visit value. Only post-baseline values were carried forward. | Posted | Mean | Standard Error | percent change | Baseline to 12 Weeks |
|
|
Up to 23 weeks
All adverse events reported from the time of study drug administration until 30 days following discontinuation of study drug were collected. Serious adverse events were collected from the time the participant signed the informed consent until 30 days following discontinuation of study drug.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | ABT-335 and Rosuvastatin Calcium | ABT-335 135 mg in combination with rosuvastatin calcium 5 mg administered orally, once daily for 12 weeks | 7 | 253 | 52 | 253 | ||
| EG001 | ABT-335 | ABT-335 135 mg monotherapy administered orally, once daily for 12 weeks | 6 | 254 | 41 | 254 | ||
| EG002 | Rosuvastatin Calcium | Rosuvastatin calcium 5 mg monotherapy administered orally, once daily for 12 weeks | 4 | 251 | 45 | 251 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA (9.1) |
| ||
| Cardiogenic shock | Cardiac disorders | MedDRA (9.1) |
| ||
| Coronary artery disease | Cardiac disorders | MedDRA (9.1) |
| ||
| Myocardial infarction | Cardiac disorders | MedDRA (9.1) |
| ||
| Pancreatitis acute | Gastrointestinal disorders | MedDRA (9.1) |
| ||
| Chest pain | General disorders | MedDRA (9.1) |
| ||
| Cyst | General disorders | MedDRA (9.1) |
| ||
| Bronchitis | Infections and infestations | MedDRA (9.1) |
| ||
| Rhabdomyolysis | Musculoskeletal and connective tissue disorders | MedDRA (9.1) |
| ||
| Lymphoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) |
| ||
| Pituitary tumour benign | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) |
| ||
| Renal cell carcinoma stage unspecified | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) |
| ||
| Aphasia | Nervous system disorders | MedDRA (9.1) |
| ||
| Cerebrovascular accident | Nervous system disorders | MedDRA (9.1) |
| ||
| Haemorrhage intracranial | Nervous system disorders | MedDRA (9.1) |
| ||
| Transient ischaemic attack | Nervous system disorders | MedDRA (9.1) |
| ||
| Anxiety | Psychiatric disorders | MedDRA (9.1) |
| ||
| Mental status changes | Psychiatric disorders | MedDRA (9.1) |
| ||
| Nephrolithiasis | Renal and urinary disorders | MedDRA (9.1) |
| ||
| Uterovaginal prolapse | Reproductive system and breast disorders | MedDRA (9.1) |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dyspepsia | Gastrointestinal disorders | MedDRA (9.1) |
| ||
| Nasopharyngitis | Infections and infestations | MedDRA (9.1) |
| ||
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) |
| ||
| Headache | Nervous system disorders | MedDRA (9.1) |
|
Abbott requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. Abbott requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if Abbott needs to secure patent or proprietary protection.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
| ID | Term |
|---|---|
| D006937 | Hypercholesterolemia |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533234 | 2-(4-(4-chlorobenzoyl)phenoxy)-2-methylpropanoic acid |
| D000068718 | Rosuvastatin Calcium |
| C006012 | fenofibric acid |
| ID | Term |
|---|---|
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
|
|
| Participants |
|
|
|
|
|
|