Clinical Trials List
2013-01-10 - 2015-12-31
Phase III
Terminated9
ICD-10E78.0
Pure hypercholesterolemia
A 24-Week, Worldwide, Multicenter, Double-Blind, Randomized, Parallel, Placebo- Controlled Study to Assess the Efficacy and Tolerability of Anacetrapib When Added to Ongoing Statin Therapy With or Without Other Lipid Modifying Medication(s) in Patients With Hypercholesterolemia or Low HDL-C
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Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
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Sponsor
Merck Sharp & Dohme Corp.
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Tse-Min Lu 新藥臨床試驗中心
- 林幸榮 新藥臨床試驗中心
- Wen-Chung Yu 新藥臨床試驗中心
- Kang-Ling Wang 新藥臨床試驗中心
- Shih-Hsien Sung 新藥臨床試驗中心
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 謝昌勳 Division of Endocrinology
- 吳令怡 Division of Endocrinology
- Chih-Tsueng He Division of Endocrinology
- 李建興 Division of Endocrinology
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Shih-Sheng Chang Division of Cardiovascular Diseases
- Po-Yen Ko Division of Cardiovascular Diseases
- 陳恬恩 Division of Cardiovascular Diseases
- 盧炯睿 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 方修御 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 黃炳賢 Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 溫文才 Division of Cardiovascular Diseases
- Cheng-An Chiu Division of Cardiovascular Diseases
- 顏學偉 Division of Cardiovascular Diseases
- Ye-Hsu Lu Division of Cardiovascular Diseases
- Tsung-Hsien Lin Division of Cardiovascular Diseases
- 朱志生 Division of Cardiovascular Diseases
- Po-Chao Hsu Division of Cardiovascular Diseases
- 鄭凱鴻 Division of Cardiovascular Diseases
- Chun-Yuan Chu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- MAO-HSIN LIN Division of Cardiovascular Diseases
- Tzung-Dau Wang Division of Cardiovascular Diseases
- Hsien Li Kao Division of Cardiovascular Diseases
- 陳盈憲 Division of Cardiovascular Diseases
- Yen-Wen Wu Division of Cardiovascular Diseases
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Percent Change from Baseline in LDL-C (beta-quantification [BQ] method) [ Time Frame: Baseline and Week 24 ]
Percent Change from Baseline in HDL-C [ Time Frame: Baseline and Week 24 ]
Number of Participants with Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) Consecutive Elevations ≥3x Upper Limit of Normal (ULN) [ Time Frame: 24 weeks ]
Number of Participants with Creatine Phosphokinase Elevations ≥10xULN with or without Muscle Symptoms [ Time Frame: 24 weeks ]
Number of Participants with Sodium, Chloride, or Bicarbonate Elevations >ULN or Potassium Levels
Number of Participants with Significant Increase in Blood Pressure [ Time Frame: 24 weeks ]
Secondary Outcome Measures :
Percent Change from Baseline in non-HDL-C [ Time Frame: Baseline and Week 24 ]
Percent Change from Baseline in Apolipoprotein B (Apo-B) [ Time Frame: Baseline and Week 24 ]
Percent Change from Baseline in Apolipoprotein A-I (Apo-A-I) [ Time Frame: Baseline and Week 24 ]
Percent Change from Baseline in Lipoprotein(a) (lp[a]) [ Time Frame: Baseline and Week 24 ]
Percent Change from Baseline in HDL-C Among Participants with Low HDL-C at LDL-C Goal [ Time Frame: Baseline and Week 24 ]
Inclution Criteria
If female, cannot be of reproductive potential
Has been treated with an appropriate dose of statin for at least 6 weeks
Coronary heart disease (CHD) or other atherosclerotic vascular disease with multiple risk factors (including diabetes, metabolic syndrome) and/or high LDL-C/low HDL-C, or needing to meet a specific LDL-C/HDL-C goal
Exclusion Criteria
Previously participated in a study with a cholesteryl ester transfer protein (CETP) inhibitor
Homozygous familial hypercholesterolemia
Severe chronic heart failure
Uncontrolled cardiac arrhythmias, myocardial infarction (MI), percutaneous coronary intervention (PCI), coronary artery by-pass graft (CABG), unstable angina, or stroke within 3 months
Uncontrolled hypertension
Uncontrolled endocrine or metabolic disease known to influence serum lipids or lipoproteins
Active or chronic hepatobiliary, hepatic, or gall bladder disease
History of mental instability, drug/alcohol abuse within the past five years or major psychiatric illness inadequately controlled and unstable
History of ileal bypass, gastric bypass, or other significant condition associated with malabsorption
Human immunodeficiency virus (HIV) positive
History of malignancy ≤5 years
Donated blood products or has had phlebotomy of >300 mL within 8 weeks or intends to donate 250 mL of blood products or receive blood products within the projected duration of the study
Currently taking medications that are potent inhibitors or inducers of cytochrome P450 3A4 (CYP3A) (including but not limited to cyclosporine, systemic itraconazole or ketoconazole, erythromycin, clarithromycin, or telithromycin, nefazodone, protease inhibitors, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin, St John's wort) or has discontinued treatment <3 weeks prior
Consumes more than 2 alcoholic drinks per day
Currently participating or has participated in a study with an investigational compound or device within 3 months
Receiving treatment with systemic corticosteroids or taking systemic anabolic agents
The Estimated Number of Participants
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Taiwan
88 participants
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Global
880 participants
