| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00300430 | Study to Evaluate the Long-Term Safety and Efficacy of ABT-335, in Combination With Three Different Statins in Subjects With Mixed Dyslipidemia. | PHASE3 | COMPLETED | 1,911 | — | — | Sep 1, 2006 | - | Jul 23, 2009 | 1 | United States |
| NCT00300456 | Evaluate Safety and Efficacy of ABT-335 in Combination With Simvastatin in Subjects With Multiple Abnormal Lipid Levels in the Blood | PHASE3 | COMPLETED | 657 | — | — | Mar 1, 2006 | - | Jun 3, 2009 | 1 | United States |
| NCT00300482 | Evaluate Safety and Efficacy of ABT-335 in Combination With Rosuvastatin Calcium in Subjects With Multiple Abnormal Lipid Levels in the Blood | PHASE3 | COMPLETED | 1,445 | — | — | Mar 1, 2006 | - | Jun 10, 2009 | 1 | United States |
| NCT00728910 | Combined Effects of Non-statin Treatments on Apolipoprotein A-I Up-Regulation (CENTAUR): A Feasibility Study | PHASE2 | COMPLETED | 25 | — | — | Jun 1, 2008 | Aug 1, 2009 | Feb 29, 2016 | 1 | United States |
\[(Week 12 triglycerides minus baseline triglycerides)/baseline triglycerides\] x 100
\[(Week 12 HDL-C minus baseline HDL-C)/baseline HDL-C\] x 100
\[(Week 12 LDL-C minus baseline LDL-C)/baseline LDL-C\] x 100
After receiving total daily caloric intake over 20 hrs as 20 identical small meals, starting at 0600 hrs, subjects took study medications at 0800 hrs. Five hours after the first meal, i.v. 5,5,5-2H3-L-leucine was administered, followed by a primed-constant infusion at 10 mol/kg body weight per hr for 15 hrs during which 14 blood samples were collected. Isotopic enrichment of leucine in apoA1 band excised from polyacrylamide gel was calculated. Assuming steady state apo A-I metabolism, we used a compartment model to fit data, consisting a precursor compartment (Compartment 1), the plasma leucine pool, an intracellular compartment accounting for apoA1 synthesis and lipoprotein assembly (Compartment 2), and compartments to account for dispositional kinetics of the subfractions including a plasma pool compartment (Compartment 3). The apoA1 FCR corresponds to the rate of irreversible loss of leucine pools from Compartment 3.
The apolipoprotein A-I production rate using (5,5,5-2H3-L-leucine) was measured following each of the three study periods i.e following 4 weeks of atorvastatin 10 mg/day, following 8 further weeks of ABT335 135 mg/day added to atorvastatin and following 10 further weeks of ER niacin 2000 mg/day and aspirin 325 mg/day added to atorvastatin+ABT335.
Triglyceride iAUC was measured during an oral fat tolerance test administered after 4 weeks of atorvastatin 10 mg/day , a further 8 weeks of atorvastatin 10mg /day+ABT335 135mg/day and then after a further 10 weeks of atorvastatin 10 mg/day+ABT335 135 mg/day+Niaspan 2000 mg/day. The standardized oral fat load was administered one hour post medication dosing and blood was collected prior to drug dosing, prior to the oral fat load and hourly thereafter for 10 hours (0,1,2,3,4,5,6,7,8,9,10,12 hrs post drug dosing)
| Arm | Type | Description |
|---|---|---|
| A | ACTIVE_COMPARATOR | 20 mg drug and ABT-335 |
| B | ACTIVE_COMPARATOR | 40 mg drug and ABT 335 |
| C | ACTIVE_COMPARATOR | 40 mg drug and ABT-335 |
| D | PLACEBO_COMPARATOR | 20 mg simvastatin monotherapy |
| E | PLACEBO_COMPARATOR | 40 mg simvastatin monotherapy |
| F | PLACEBO_COMPARATOR | 80 mg simvastatin monotherapy |
| Atorvastatin | ACTIVE_COMPARATOR | atorvastatin 10 mg/day by mouth for a total duration of 4 weeks |
| ABT335 | ACTIVE_COMPARATOR | ABT335 135 mg/day by mouth added to atorvastatin for a total duration of at least 8 |
| ER niacin | ACTIVE_COMPARATOR | ER niacin titrated up to 2 g/day with aspirin 325 mg/day by mouth added to atorvastatin and ABT335 for 10 weeks |
| Name | Type | Description |
|---|---|---|
| ABT-335 and rosuvastatin calcium | DRUG | ABT-335 135 mg plus rosuvastatin calcium daily, 52 weeks |
| ABT-335 and atorvastatin calcium | DRUG | ABT-335 135 mg plus atorvastatin calcium daily, 52 weeks |
| ABT-335 and simvastatin | DRUG | ABT-335 135 mg plus simvastatin daily, 52 weeks |
| ABT-335 | DRUG | 135 mg, daily, 12 weeks |
| Simvastatin | DRUG | daily, 12 weeks, see Arm Description for dosage information |
| Placebo | DRUG | Daily, 12 weeks, see Arm Description for placebo information |
| Rosuvastatin Calcium | DRUG | Daily, 12 weeks, see Arm Description for dosage information |
| Atorvastatin | DRUG | 10 mg QD for 4 weeks |
| ABT335 | DRUG | 135 mg QD added to atorvastatin for 8 weeks |
| ER Niacin | DRUG | 2000 mg QD added to atorvastatin and ABT335 for 10 weeks |
Inclusion Criteria: * Adult male and female subjects who voluntarily sign the informed consent. * Subject has successfully completed one of the three ABT-335, rosuvastatin, simvastatin and atorvastatin combination therapy studies. Exclusion Criteria: * Subject is using or will use investigational...