Trials / Completed
CompletedNCT02659397
A Study Of Pharmacokinetics, Pharmacodynamics And Safety Of Adding ETC-1002 To Atorvastatin 80 mg
A Study to Assess the Pharmacokinetics, Pharmacodynamics and Safety of Adding ETC-1002 180 mg to Atorvastatin 80 mg Background Therapy in Statin-Treated Patients
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 68 (actual)
- Sponsor
- Esperion Therapeutics, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this research study is to measure the amount of atorvastatin and ETC-1002 in the blood, to determine how ETC-1002 affects the level of LDL-cholesterol (bad cholesterol) and other markers of health and disease in blood and urine, and to see how ETC-1002 is tolerated in the body compared to placebo when added to stable atorvastatin 80 mg background therapy in statin-treated patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ETC-1002 | Blinded ETC-1002 180 mg tablet once daily for 4 weeks (Weeks 1 to 4) |
| DRUG | Atorvastatin | Atorvastatin 80 mg tablet once daily for 8 weeks (Weeks -4 to 4) |
| DRUG | Placebo | Blinded ETC-1002-matched placebo tablet once daily for 4 weeks (Weeks 1 to 4) |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2016-07-01
- Completion
- 2016-07-01
- First posted
- 2016-01-20
- Last updated
- 2019-03-29
Locations
19 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02659397. Inclusion in this directory is not an endorsement.