NCT01779453

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2012

Shorter than P25 for phase_2

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2012

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

December 14, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 30, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

March 29, 2019

Status Verified

March 1, 2019

Enrollment Period

8 months

First QC Date

December 14, 2012

Last Update Submit

March 26, 2019

Conditions

Hypercholesterolemia

Keywords

AtorvastatinDrug-drug interactionCombination therapy

Outcome Measures

Primary Outcomes (3)

  • Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites

    4 and 8 weeks

  • Peak plasma concentration (Cmax) of atorvastatin and its active metabolites

    4 and 8 weeks

  • Number of subjects with adverse events, clinical lab abnormalities and other safety findings

    8 weeks

Secondary Outcomes (2)

  • Percent change in LDL-C

    2, 4, 6 and 8 weeks

  • Percent change in other lipids and cardio-metabolic risk factors

    2, 4, 6 and 8 weeks

Other Outcomes (1)

  • Area under the plasma concentration versus time curve (AUC) and peak plasma concentration (Cmax) of ETC-1002 and its active metabolite

    4 and 8 weeks

Study Arms (2)

ETC-1002

EXPERIMENTAL

ETC-1002 treatment group, oral once daily

Drug: ETC-1002Drug: Atorvastatin

Placebo

PLACEBO COMPARATOR

Placebo treatment group, oral once daily

Drug: PlaceboDrug: Atorvastatin

Interventions

ETC-1002DRUG

Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day

ETC-1002
PlaceboDRUG

Placebo once daily for 8 weeks

Placebo
AtorvastatinDRUG

Atorvastatin 10mg once daily for 8 weeks

ETC-1002Placebo

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Acute significant cardiovascular disease
  • Uncontrolled hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Unknown Facility

Indianapolis, Indiana, 46260, United States

Location

Unknown Facility

Louisville, Kentucky, 40213, United States

Location

Unknown Facility

Richmond, Virginia, 23294, United States

Location

MeSH Terms

Conditions

Hypercholesterolemia

Interventions

8-hydroxy-2,2,14,14-tetramethylpentadecanedioic acidAtorvastatin

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PyrrolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeptanoic AcidsFatty AcidsLipids

Study Officials

  • Noah Rosenberg, MD

    Esperion Therapeutics, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2012

First Posted

January 30, 2013

Study Start

December 1, 2012

Primary Completion

August 1, 2013

Study Completion

August 1, 2013

Last Updated

March 29, 2019

Record last verified: 2019-03

Locations

US(3)