HypercholesterolemiaPhase 2NCT01779453
A Study of the Safety, Pharmacokinetic Drug Interaction and Efficacy of ETC-1002 and Atorvastatin in Subjects With Hypercholesterolemia
A Phase 2 study testing ETC-1002 and Atorvastatin in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hypercholesterolemia
- What is being tested?
- ETC-1002 and Atorvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 58 participants
- Where
- 3 sitesUnited States
- Study dates
- Dec 2012to Aug 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Acute significant cardiovascular disease
- Uncontrolled hypertension
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Study site
Indianapolis, Indiana, 46260
Study site
Louisville, Kentucky, 40213
Study site
Richmond, Virginia, 23294
About this study
Official title: 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.
- Conditions
- Hypercholesterolemia
- Being tested
- ETC-1002, Placebo, Atorvastatin
- Keywords
- Atorvastatin, Drug-drug interaction, Combination therapy
- Medical subject headings
- Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboDrug
Placebo once daily for 8 weeks
AtorvastatinDrug
Atorvastatin 10mg once daily for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| ETC-1002 | Experimental | ETC-1002 treatment group, oral once daily Receives: Drug: ETC-1002; Drug: Atorvastatin |
| Placebo | Placebo comparator | Placebo treatment group, oral once daily Receives: Drug: Placebo; Drug: Atorvastatin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
Measured: 4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
Measured: 4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
Measured: 8 weeks
Secondary outcomes (2)
Percent change in LDL-C
Measured: 2, 4, 6 and 8 weeks
Percent change in other lipids and cardio-metabolic risk factors
Measured: 2, 4, 6 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startDec 2012
- Primary completionAug 2013
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypercholesterolemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Esperion Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Noah Rosenberg, MD, Study director, Esperion Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779453
- Sponsor's protocol ID
- 1002-007
- Status last verified
- Mar 2019
- First submitted
- 14 Dec 2012
- Last updated
- 29 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01779453
- Acronym / sponsor ID
- 1002-007
- Conditions
- Hypercholesterolemia
- Keywords
- Atorvastatin, Drug-drug interaction, Combination therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Esperion Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2012
- Primary completion
- Aug 2013 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 30 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ETC-1002 | Experimental | Drug: ETC-1002, Drug: AtorvastatinETC-1002 treatment group, oral once daily |
| Placebo | Placebo comparator | Drug: Placebo, Drug: AtorvastatinPlacebo treatment group, oral once daily |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- Acute significant cardiovascular disease
- Uncontrolled hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ETC-1002Week 1-2, 60 mg/day; Week 3-4, 120 mg/day; Week 5-6, 180 mg/day; Week 7-8, 240 mg/day | Drug | ETC-1002 |
| PlaceboPlacebo once daily for 8 weeks | Drug | Placebo |
| AtorvastatinAtorvastatin 10mg once daily for 8 weeks | Drug | ETC-1002, Placebo |
Primary outcome
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites
Time frame: 4 and 8 weeks
Peak plasma concentration (Cmax) of atorvastatin and its active metabolites
Time frame: 4 and 8 weeks
Number of subjects with adverse events, clinical lab abnormalities and other safety findings
Time frame: 8 weeks
2 secondary outcomes
Percent change in LDL-C
Time frame: 2, 4, 6 and 8 weeks
Percent change in other lipids and cardio-metabolic risk factors
Time frame: 2, 4, 6 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Noah Rosenberg, MD study director
Esperion Therapeutics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ETC-1002 and Atorvastatin in people with Hypercholesterolemia, run by Esperion Therapeutics, Inc. at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Area under the plasma concentration versus time curve (AUC) of atorvastatin and its active metabolites (time frame: 4 and 8 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2019.