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Completed

NCT Number: NCT02178098

Evaluation of ETC-1002 in Participants With Hypercholesterolemia and Hypertension

This Phase 2 study will assess the efficacy and safety of ETC-1002 monotherapy versus placebo in participants with hypercholesterolemia and hypertension.

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Key information

Conditions

Hypercholesterolemia Cardiovascular Diseases Dyslipidemias Hyperlipidemias Hypertension Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Birmingham, Alabama, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Mean 24-hour ambulatory SBP greater than or equal to 130 mmHg
  • or- Mean 24-hour ambulatory DBP greater than or equal to 80 mmHg
  • Fasting LDL-C between 100 and 220 mg/dL
  • Fasting triglycerides less than 400 mg/dL
  • Body mass index (BMI) between 18 and 45 kg/m2

Exclusion criteria

  • Known or suspected secondary hypertension or history of malignant hypertension
  • Taking more than two anti-hypertension medications at the first visit
  • History or current clinically significant cardiovascular disease
  • History or current type 1 diabetes or type 2 diabetes

Treatment and study plan

ETC-1002

Drug

ETC-1002 capsules taken once daily

Placebo

Drug

Placebo capsules taken once daily

Primary outcomes

  1. Percent Change From Baseline in Calculated Low-density Lipoprotein Cholesterol (LDL-C) to Week 6

    Time frame: Baseline; 6 weeks

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Percent change from Baseline in LDL-C was analyzed using an analysis of covariance (ANCOVA) model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value. For the Week 6 endpoint, missing values at Week 6 were imputed using the last observation carried forward (LOCF) procedure, with only post-Baseline values carried forward. Modified Intent-to-Treat (mITT) Population is defined as all randomized participants who received at least 1 dose of study drug, had a Baseline assessment, and had at least 1 post-Baseline assessment, excluding any assessment taken more than 2 days after a dose of study drug

Secondary outcomes

  1. Change From Baseline in Mean 24-hour Systolic Blood Pressure (SBP) to Week 6

    Time frame: Baseline; 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.

  2. Change From Baseline in 24-hour Mean Diastolic Blood Pressure (DBP) to Week 6

    Time frame: Baseline; 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.

  3. Change From Baseline in Mean Daytime SBP to Week 6

    Time frame: Baseline; 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Daytime measurements were defined as those taken from 7 AM to 10 PM (>7 AM and ≤10 PM). The Week 6 endpoint was the last available post-Baseline value.

  4. Change From Baseline in Mean Daytime DBP to Week 6

    Time frame: Baseline; 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Daytime measurements were defined as those taken from 7 AM to 10 PM (>7 AM and ≤10 PM). The Week 6 endpoint was the last available post-Baseline value.

  5. Change From Baseline in Mean Nighttime SBP to Week 6

    Time frame: Baseline; 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Nighttime measurements were defined as those taken from 10 PM to 7 AM (>10 PM and ≤7 AM). The Week 6 endpoint was the last available post-Baseline value.

  6. Change From Baseline in Mean Nighttime DBP to Week 6

    Time frame: Baseline; 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Nighttime measurements were defined as those taken from 10 PM to 7 AM (>10 PM and ≤7 AM). The Week 6 endpoint was the last available post-Baseline value.

  7. Change From Baseline in Sitting Cuff SBP to Week 6

    Time frame: Baseline: 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the mean of the values from Weeks -1 and 0. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Three BP measurements were collected at least 3 minutes apart, and the mean of the second and third measurements was calculated and used for summary and analysis. The Week 6 endpoint was the last available post-Baseline value.

  8. Change From Baseline in Sitting Cuff DBP to Week 6

    Time frame: Baseline; 6 weeks

    Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Baseline was defined as the mean of the values from Weeks -1 and 0. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. Three BP measurements were collected at least 3 minutes apart, and the mean of the second and third measurements was calculated and used for summary and analysis. The Week 6 endpoint was the last available post-Baseline value.

  9. Percent Change From Baseline in High-sensitivity C-reactive Protein (hsCRP) to Week 6

    Time frame: Baseline; 6 weeks

    A non-parametric analysis was performed for hsCRP parameters. Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the last value prior to the first dose of study medication. If hsCRP was <0.2, 0.1 was imputed for analysis. The Week 6 endpoint was the last available post-Baseline value.

  10. Percent Change From Baseline in Total Cholesterol to Week 6

    Time frame: Baseline; 6 weeks

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and value as a covariate. The Week 6 endpoint was the last available post-Baseline value.

  11. Percent Change From Baseline in Apolipoprotein B (ApoB) to Week 6

    Time frame: Baseline; 6 weeks

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.

  12. Percent Change From Baseline in Non-high-density Lipoprotein Cholesterol (Non-HDL-C) to Week 6

    Time frame: Baseline; 6 weeks

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the last value prior to the first dose of study medication. Change from Baseline was calculated using an ANCOVA model with a term for treatment and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.

  13. Percent Change From Baseline in Triglycerides (TG) to Week 6

    Time frame: Baseline; 6 weeks

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. The Week 6 endpoint was the last available post-Baseline value. Data was analyzed using non-parametric analysis.

  14. Percent Change From Baseline in HDL-C to Week 6

    Time frame: Baseline; 6 weeks

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated using an ANCOVA model with terms for treatment and statin intolerance, and Baseline value as a covariate. The Week 6 endpoint was the last available post-Baseline value.

  15. Percent Change From Baseline in Free Fatty Acids (FFA) to Week 6

    Time frame: Baseline; 6 weeks

    Percent change from Baseline was calculated as the ([post-Baseline value minus the Baseline value] divided by the Baseline value) x 100. Baseline was defined as the mean of the values from Week -1 and Week 0. The Week 6 endpoint was the last available post-Baseline value.

  16. Change From Baseline in Body Weight to Week 6

    Time frame: Baseline; 6 weeks

    Baseline was defined as the mean of the values from Week -1 and Week 0. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.

  17. Plasma Trough Concentrations of ETC-1002 and Metabolite ESP15228

    Time frame: Week 2, Week 4 and Week 6

    Plasma trough concentration is defined as the lowest concentration reached before the next dose is administered.

Sponsors and collaborators

Lead sponsor

Esperion Therapeutics, Inc.

Industry

Collaborators

  • Medpace, Inc.

Registry information

Official study title

A Placebo-Controlled, Randomized, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ETC-1002 in Patients With Hypercholesterolemia and Hypertension

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 30, 2014
Registry last updated
Apr 4, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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