A clinical trial to study the effects of Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg with Rosuvastatin 10 mg alone in patients with dyslipidemia
- Registration Number
- CTRI/2010/091/001490
- Lead Sponsor
- M/s. GKM New Pharma
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 200
Male and female outpatients ³ 18 but < 75 years of age.
1.Patients with dyslipidemia meeting the following criteria.
a.LDL Cholesterol > 130 mg/dL.
b.Serum Triglycerides > or equal to 150 mg/dL and < or equal to 500 mg/dL.
2.Able to stop current statin therapy without risk to the patient.
3.Patients who are able and are willing to comply with the protocol and have signed IEC or IRB approved Informed Consent Form.
4.Patients who are able to adequately maintain the diary.
1.Not willing to sign the ICF,
2.Hypersensitivity to statins.
3.Serum Triglyceride levels > 500 mg/dL
4.Patients with abnormal clinical chemistry, hematology, urinalysis, or ECG test results that are considered clinically significant by the investigator.
5.Patients with significant hepatic disease (liver function tests x 2 upper limit of normal reference range) or significant renal disease (creatinine x 2 upper limit of normal reference range).
6.Poorly controlled diabetes mellitus (glycosylated hemoglobin >8.0% )or diabetes mellitus requiring insulin therapy
7.Bilateral renal artery stenosis, renal artery stenosis in a solitary kidney, patients post-renal transplant or with only one functioning kidney
8.Patients familiar with muscular pain, myopathy
9.History of drug or alcohol dependency within the previous six months. Chronic administration of any medication known to affect blood pressure, other than the trial medication
10.Concurrent participation in another clinical trial or any investigational therapy within thirty days prior to signing the consent form.
11.Symptomatic congestive heart failure (New York Heart Academy (NYHA) functional class CHF III-IV) - unstable angina pectoris, myocardial infarction, percutaneous transluminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG) surgery less than three months prior to informed consent
12.Stroke less than six months prior to informed consent
13.Sustained ventricular tachycardia, atrial fibrillation, atrial flutter or other clinically relevant arrhythmias as determined by the investigator.
14.Any other clinical condition which, in the opinion of the investigator, would not allow safe completion of the protocol and safe administration of Rosuvastatin
15.Patients with concomitant diseases such as malignancy, HIV
16.Pregnancy and lactation
17.History of pancreatitis
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method