Efficacy and Safety of Gemcabene in Patients With Low HDL‐C and Either Normal or Elevated Triglycerides

Hypercholesterolemia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02585869
• Other study ID #: 1027-004
• Status: Completed
• Phase: Phase 2
• Start date: December 1999
• Est. completion date: June 2001

Study information

• Verified date: April 2020
• Source: NeuroBo Pharmaceuticals Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: June 2001
• Est. primary completion date: June 2001
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypercholesterolemia
• Hypertriglyceridemia

Intervention

Drug:
• Gemcabene 150 mg
Blinded capsules and tablets, 150 mg, once daily, 84 days
• Gemcabene 300 mg
Blinded capsules and tablets, 300 mg, once daily, 84 days
• Gemcabene 600 mg
Blinded capsules and tablets, 600 mg, once daily, 84 days
• Gemcabene 900 mg
Blinded capsules and tablets, 900 mg, once daily, 84 days
• Placebo
Blinded capsule and tablets, once daily, 84 days

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

References & Publications (1)

Bays HE, McKenney JM, Dujovne CA, Schrott HG, Zema MJ, Nyberg J, MacDougall DE; Gemcabene Study Group. Effectiveness and tolerability of a new lipid-altering agent, gemcabene, in patients with low levels of high-density lipoprotein cholesterol. Am J Cardiol. 2003 Sep 1;92(5):538-43. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HDL-C - percent change from baseline		84 days
Secondary	Plasma lipids (eg, LDL-C, VLDL-C, TG)- percent change from baseline		84 days
Secondary	Adverse Events		84 days
Secondary	Clinical Laboratory - hematology, chemistry, urinalysis	Clinical Laboratory Abnormalities	84 days