A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia

Esperion Therapeutics

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Atorvastatin; Drug: ETC-1002

Study type: Interventional

Funder types: Industry

Identifiers

NCT01779453

1002-007

Details and patient eligibility

About

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.

Enrollment: 58 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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58 participants in 2 patient groups, including a placebo group

ETC-1002

Experimental group

Description:

ETC-1002 treatment group, oral once daily

Treatment:

Drug: ETC-1002

Drug: Atorvastatin

Placebo

Placebo Comparator group

Description:

Placebo treatment group, oral once daily

Treatment:

Drug: Placebo

Drug: Atorvastatin