Status:
WITHDRAWN
Study of MB07811 in Subjects With Hypercholesterolemia
Lead Sponsor:
Ligand Pharmaceuticals
Conditions:
Hypercholesterolemia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
A Phase 2 randomized, placebo controlled study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects with primary hypercholesterolemia for 12 weeks followed by a 6-week ...
Detailed Description
This is an outpatient, Phase 2, multicenter, double-blind, placebo-controlled, randomized, parallel-group study assessing the efficacy, safety, and tolerability of MB07811 given orally to subjects wit...
Eligibility Criteria
Inclusion
- Body mass index (BMI) 18.50 - 40 kg/m2 inclusive at screening;
- Fasting serum LDL-C ≥145 mg/dL at both Q2 and Q3 visits;
- Fasting mean serum LDL-C \<220 mg/dL from Q2 and Q3;
Exclusion
- History of clinically significant cardiovascular disease
- Uncontrolled hypertension
- Significant sinus bradycardia defined as \<40 beats per minute (bpm);
- Personal or family history of clinically significant unexplained syncope, near-syncope or unexplained sudden death or QT syndrome;
- Holter monitor report demonstrating any abnormality that is clinically significant, including but not limited to PVC frequency \> 1 per minute, any alert criteria or any other condition that requires further evaluation;
- History of clinical significant arrhythmia;
- Resting 12-lead ECG showing QTc \>450 msec or \<360 msec (males or females), any tachyarrhythmia or morphology change, or any other clinically significant abnormality;
- Any other cardiovascular event requiring hospitalization;
- History or presence of thyroid disorder or other metabolic/endocrine disorder that affects lipids or glucose; Exceptions: polycystic ovarian syndrome (PCOS) and impaired glucose tolerance (IGT) are allowed.
- Liver disease, gallbladder disease, Gilbert's syndrome, biopsy-proven nonalcoholic steatohepatitis (NASH), positive serology for hepatitis B surface antigen (HBsAg) or hepatitis C antibodies; Exceptions: gallbladder disease treated with cholecystectomy
- History of human immunodeficiency virus (HIV);
- Subjects with a prior history of malignancy in past 5 years;Exceptions: Subjects with previous history of basal or squamous cell carcinoma of the skin, or cervical cancer in situ are allowed if successfully treated;
- History of myopathy, including any history of statin-induced myopathy;
- History of intolerance to statins (e.g., myalgias, elevated liver tests);
- History of clinically significant psychiatric disorders, including but not limited to bipolar disorder, major depressive disorder, psychosis;
- Renal dysfunction;
- Alcohol and/or drug abuse within 12 months prior to screening;
Key Trial Info
Start Date :
April 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2009
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT00879112
Start Date
April 1 2009
End Date
December 1 2009
Last Update
August 12 2011
Active Locations (11)
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1
Scripps Clinic, Clinical Research
San Diego, California, United States, 92128
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States, 32216
3
University Clinical Research
Pembroke Pines, Florida, United States, 33024
4
Radiant Research
Chicago, Illinois, United States, 60654