STUDY OF PITAVASTATIN 2 MG vs. ATORVASTATIN 10 MG AND PITAVASTATIN 4 MG vs. ATORVASTATIN 20 MG (FOLLOWING UP-TITRATION) IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR COMBINED DYSLIPIDEMIA
- Conditions
- Primary Hypercholesterolemia or Combined DyslipidemiaMedDRA version: 7.1Level: LLTClassification code 10020604
- Registration Number
- EUCTR2005-001000-39-ES
- Lead Sponsor
- Kowa Research Europe Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 200
1. Males and females (age 18-75 years). Non-pregnant, non-lactating females;
2. Women of child bearing potential are allowed to enter the study ONLY if they use sustained contraceptive preparations (e.g., implants or intramuscular (IM) injections) or comply with an approved mechanical contraceptive method. A woman is considered to be of childbearing potential unless she is post hysterectomy or at least 1-year post-menopausal or post-tubal ligation. All women of child bearing potential must have a negative pregnancy test at the beginning of the dietary lead-in period (Visit 1/Week 8/ 6), and before initiating active treatment (Visit 4/Week 0);
3. Patients who are eligible and able to participate in the study and who have given informed consent after the purpose and nature of the investigation has been explained to them;
4. In order to qualify for randomization, patients must have been following a fat and cholesterol restrictive diet as advised by the EAS during the dietary stabilization lead-in period (i.e. for at least 8 weeks for those patients previously taking lipid lowering medication and at least 6 weeks for those not previously taking lipid lowering medication). Patients must also agree not to eat grapefruit or drink grapefruit juice for the duration of the study;
5. In order to qualify for randomization at Visit 4 (Week 0), patients must present with primary hypercholesterolemia or combined dyslipidemia, as defined by elevated plasma LDL C [LDL C =4.2 mmol/L (160 mg/dL) =5.7 mmol/L (220 mg/dL)] despite dietary therapy and elevated TG levels of =4.6 mmol/L (400 mg/dL) at 2 visits (the mean of the 2 visits will be used) during the dietary lead-in period. If these criteria are not satisfied at Visit 2 (Week –2) and Visit 3 (Week –1), or if the LDL C concentration of the lower qualifying specimen differs by =15% from the higher qualifying specimen, 1 additional lipid sample will be permitted for both variables 1 week after Visit 3 (Visit 3A) to enable the patient to qualify for randomization; and
6. Patients who agree to be available for every clinic visit, which will occur in the morning.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
1. Homozygous familial hypercholesterolemia (heterozygous component of familial hypercholesterolemia is acceptable for inclusion) or familial hypoalphalipoproteinemia
2. Any conditions which may cause secondary dyslipidemia.
3. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of any drug.
4. Liver injury, uncontrolled diabetes mellitus, imparied renal function
5. Current obstruction of the urinary tract or difficulty in voiding due to mechanical as well as inflammatory conditions, which is likely to require intervention during the course of the study or is regarded as clinically meaningful by the investigator
6. Any history of pancreatic injury or pancreatitis, or impaired pancreatic function/injury as indicated by abnormal lipase or amylase;
7. Any severe acute illness or severe trauma in the last 3 months prior to Visit 1
8. Major surgery, during the 3 months prior to Visit 1
9. Significant CVD prior to randomization, such as myocardial infarction, coronary or peripheral artery angioplasty, bypass graft surgery or severe or unstable angina pectoris within the last 3 months
10. Evidence of symptomatic heart failure (New York Heart Association (NYHA) class III or IV), gross cardiac enlargement (cardiothoracic ratio >0.5); significant heart block or cardiac arrhythmias.
11. Left ventricular (LV) ejection fraction <0.25
12. Known Human Immunodeficiency Virus (HIV) infection
13. Poorly controlled or uncontrolled hypertension. Patients must have a systolic blood pressure (SBP)=160 mmHg and diastolic blood pressure (DBP)=90 mmHg with or without antihypertensive therapy.
14. Prior or current known muscular or neuromuscular disease of any type
15. Within the last 2 years, a history of drug abuse or continuous consumption of more than 65 mL pure alcohol per day
16. Exposure to any investigational new drug within 30 days of study entry
17. History of hypersensitivity reactions to other HMG-CoA reductase inhibitors
18. History of being resistant to lipid-lowering medications
19. Excessive obesity defined as Body Mass Index (BMI) above 35 kg/m2
20. Any signs of mental dysfunction or other factors
21. Current or recent (within 4 weeks of Visit 1/Week 8/ 6) use of supplements known to alter lipid metabolism e.g. soluble fibers (including >2 teaspoons Metamucil or psyllium containing supplement per day), or other dietary fiber supplements, fish oils, or other products at the discretion of the investigator;
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method