Efficacy and Safety of Gemcabene in Hypercholesterolemic Patients as Monotherapy or in Combination With Atorvastatin

Hypercholesterolemia Clinical Trial

Official title:

An 8‐Week, Double‐Blind, Randomized, Placebo‐Controlled, Dose‐Ranging Study of the Efficacy and Safety of Gemcabene Administered as Monotherapy or in Combination With Atorvastatin in the Treatment of Hypercholesterolemic Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02591836
• Other study ID #: A4141001
• Status: Completed
• Phase: Phase 2
• Start date: January 2003
• Est. completion date: June 2003

Study information

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

Clinical Trial Summary

The primary purpose of this placebo-controlled study is to evaluate the low‐density lipoprotein cholesterol (LDL‐C) efficacy and dose‐response of gemcabene 300, 600 and 900 mg/day administered as monotherapy or in combination with atorvastatin 10, 40, and 80 mg/day to hypercholesterolemic patients.

Secondary purposes include evaluating the effects of high‐sensitivity C-reactive protein (hsCRP), high‐density lipoprotein cholesterol (HDL‐C), triglycerides (TG) and apolipoprotein B (ApoB), and safety and efficacy of gemcabene monotherapy and gemcabene/atorvastatin combination.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 277
• Est. completion date: June 2003
• Est. primary completion date: June 2003
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Males and Females

• 18-70 years old

• Received a statin as monotherapy while having a LDL-C >100 mg d/L at initial clinical washout visit OR

• Received no lipid-altering drugs since the initial clinic washout visit and had a mean LDL-C as follows at 2 qualifying visits:

• = 130 mg/dL if National Cholesterol Education Program (NCEP) Adult Treatment Panel III (ATP III) Coronary Heard Disease (CHD) risk = 10%; OR

• = 160 mg/dL if NCEP ATP III CHD risk < 10%

• Had variability of 2 qualifying LDL-C <20% (i.e. lowest value/highest value >0.8). An additional qualifying visit may have been completed by patients who were washing off lipid medication in order to reassess LDL-C variability; and

• Had a mean LDL-C < 250 mg/dL at 2 qualifying visits

Exclusion Criteria:

• Women of childbearing potential, pregnant or lactating;

• Body Mass Index (BMI) >38kg/m²;

• TG >400 mg/dL at Visit B2 or B3

• Unexplained creatinine phosphokinase (CPK) > 3 x Upper Limit of Normal (ULN) or those with a history of unexplained myopathy (including rhabdomyolysis);

• Documented cardiac history of: Myocardial infarction*, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass graft, symptomatic carotid artery disease or peripheral artery disease, ventricular arrhythmias, recurrent supraventricular tachycardia, abnormal QTC interval (QT corrected > 0.44 sec), heart failure or any other major cardiovascular event resulting in hospitalization

• Uncontrolled hypertension*

• Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (HbA1c >8%) or any diabetic patient who takes insulin and/or thiazolidinediones

• Renal dysfunction including chronic renal failure or insufficiency, or creatinine >2.0 mg/dL;

• Hepatic dysfunction

• Uncontrolled hypothyroidism

• Abnormal urinalysis

• Currently taking any of the following medications:

• Potent CYP3A4 inhibitors including indinavir, nelfinavir, ritonavir, saquinavir, amiodarone, cimetidine, clarithromycin, erythromycin, erythromycin, fluoxetine, itraconazole, ketoconazole, nefazodone and troleandomycin as well as grapefruit juice;

• Thiazolidinediones (Avandia, Actos);

• Immunosuppressive agents;

• St. John's wort

• Taking any of the following lipid-altering medications within 5 weeks prior to randomization:

• Lipid-regulating drugs: Niacin (crystalline >500mg/day, slow release or time release), psyllium preparation such as Metamucil (>2 tablespoons/day), fibrates and derivatives, bile cholesterol absorption inhibitors including ezetimibe;

• Any supplement containing plan sterols/stanols (i.e. Benecol, beta-sitosterol, Cholestatin, Phytoquest, Take Control) or cholestin (i.e. Chinese red yeast, fermented on rice; Hong Qu, Hong Chu, Herbvalin, Ruby Monascus, Monascus purpureus rice);

• Neomycin (oral);

• Adrenocortical steroids*

• Sibutramine (Meridia);

• Insulin;

• Orlistat (Xenical);

• Isotretinoin

Related Conditions & MeSH terms

• Hypercholesterolemia

Intervention

Drug:
• Gemcabene
Gemcabene
• Atorvastatin
Atorvastatin
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
NeuroBo Pharmaceuticals Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LDL-C percent change from baseline		56 days
Secondary	HDL-C percent change from baseline		56 days
Secondary	TG percent change from baseline		56 days
Secondary	Apolipoprotein-B percent change from baseline		56 days
Secondary	Adverse Events		56 days
Secondary	Clinical Laboratory	Clinical Laboratory Abnormalities	56 days