A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
| Status: | Completed |
|---|---|
| Conditions: | High Cholesterol |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/31/2019 |
| Start Date: | December 2012 |
| End Date: | August 2013 |
A Placebo-Controlled, Randomized, Double-Blind, Parallel Group, Drug Interaction Study to Evaluate the Safety, Tolerability and Effect on Atorvastatin Pharmacokinetics of ETC-1002 Added to Atorvastatin 10 mg/Day in Subjects With Hypercholesterolemia
This study will assess the safety, atorvastatin pharmacokinetics, and LDL-C lowering efficacy
of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of
atorvastatin 10 mg.
of ETC-1002 versus placebo in hypercholesterolemic subjects on background therapy of
atorvastatin 10 mg.
Inclusion Criteria:
- For subjects on current daily statin therapy - LDL-C 100-220 mg/dL and triglycerides
<350 mg/dL (prior to switching to sponsor -provided atorvastatin 10 mg/day and
stopping all other lipid-regulating drugs and supplements) at the S1 Visit,
- For subjects not on current daily statin therapy - LDL-C ≥ 110 mg/dL and ≤ 220 mg/dL
Exclusion Criteria:
- Acute significant cardiovascular disease
- Uncontrolled hypertension
We found this trial at
3
sites
Click here to add this to my saved trials
Click here to add this to my saved trials
Click here to add this to my saved trials