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Trial record 1 of 1 for:    02585869
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Efficacy and Safety of Gemcabene in Patients With Low HDL‐C and Either Normal or Elevated Triglycerides

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier:
NCT02585869
First received: October 22, 2015
Last updated: NA
Last verified: October 2015
History: No changes posted
  Purpose
The purpose of this study is to evaluate the effect of gemcabene on HDL‐C, LDL‐C, TG, and other lipid levels in patients with low HDL‐C

Condition Intervention Phase
Hypercholesterolemia Hypertriglyceridemia Drug: Gemcabene 150 mg Drug: Gemcabene 300 mg Drug: Gemcabene 600 mg Drug: Gemcabene 900 mg Drug: Placebo Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A 12‐Week, Double‐Blind, Placebo‐Controlled, Randomized, Multicenter Study to Determine the Efficacy and Safety of CI‐1027 in Patients With Low HDL‐C and Either Normal or Elevated Triglycerides

Resource links provided by NLM:


Further study details as provided by Gemphire Therapeutics, Inc.:

Primary Outcome Measures:
  • HDL‐C ‐ percent change from baseline [ Time Frame: 84 days ]

Secondary Outcome Measures:
  • Plasma lipids (eg, LDL‐C, VLDL‐C, TG)- percent change from baseline [ Time Frame: 84 days ]
  • Adverse Events [ Time Frame: 84 days ]
  • Clinical Laboratory - hematology, chemistry, urinalysis [ Time Frame: 84 days ]
    Clinical Laboratory Abnormalities


Enrollment: 161
Study Start Date: December 1999
Study Completion Date: June 2001
Primary Completion Date: June 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Gemcabene 150 mg
Gemcabene 150 mg once daily (QD)
Drug: Gemcabene 150 mg
Blinded capsules and tablets, 150 mg, once daily, 84 days
Experimental: Gemcabene 300 mg
Gemcabene 300 mg once daily (QD)
Drug: Gemcabene 300 mg
Blinded capsules and tablets, 300 mg, once daily, 84 days
Experimental: Gemcabene 600 mg
Gemcabene 600 mg once daily (QD)
Drug: Gemcabene 600 mg
Blinded capsules and tablets, 600 mg, once daily, 84 days
Experimental: Gemcabene 900 mg
Gemcabene 900 mg once daily (QD)
Drug: Gemcabene 900 mg
Blinded capsules and tablets, 900 mg, once daily, 84 days
Placebo Comparator: Placebo
Placebo once daily (QD)
Drug: Placebo
Blinded capsule and tablets, once daily, 84 days

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Men or naturally postmenopausal or surgically menopausal women
  • 18 to 80 years of age
  • Baseline HDL‐C <35 mg/dL (0.9 mmol/L)

Exclusion Criteria:

  • Creatine phosphokinase (CPK) >3 × the upper limit of normal (ULN)
  • Body Mass Index (BMI) >35 kg/m2
  • Uncontrolled Hypertension >95 mm Hg
  • Uncontrolled diabetes mellitus (HbA1c >10%)
  • Renal dysfunction (blood urea nitrogen [BUN] or creatinine >2 × ULN);
  • Hepatic dysfunction (aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 × ULN)
  • Uncontrolled hypothyroidism (TSH >1.5 × ULN)
  • Myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, or any other major cardiovascular event resulting in hospitalization in previous 3 months
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Gemphire Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT02585869     History of Changes
Other Study ID Numbers: 1027-004
Study First Received: October 22, 2015
Last Updated: October 22, 2015

Keywords provided by Gemphire Therapeutics, Inc.:
Lipid Regulator
TG

Additional relevant MeSH terms:
Hypercholesterolemia
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on July 26, 2017