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

Phase 3

• Conditions: Dyslipidemia

• Registration Number: CTRI/2010/091/001490
• Lead Sponsor: M/s. GKM New Pharma

Brief Summary

This study is A Multicentric, Open-Label, Randomized, Comparative, Parallel-group, Active-Controlled Phase III Clinical Trial of the Safety and Efficacy of Fixed-dose combination capsules of Rosuvastatin 10 mg and Aspirin 150 mg with Rosuvastatin 10 mg alone in patients with dyslipidemia that will be conducted in four centres in India

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 200

Inclusion Criteria

• 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.

Exclusion Criteria

• 1.Not willing to sign the ICF,2.Hypersensitivity to statins.3.Serum Triglyceride levels > 500 mg/dL4.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 therapy7.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, myopathy9.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 lactation17.History of pancreatitis.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
oChange from baseline values of LDL-C at the last visit at 12 weeks.oChange from baseline values of serum triglycerides at the last visit at 12 weeksoChange from baseline values of HDL-C at the last visit at 12 weeks	12 weeks

Secondary Outcome Measures

Name	Time	Method
oAchievement of target levels of total cholesterol and LDL-cholesteroloNumber of patients achieving target levels of lipid levels ? treatment respondersoPatient compliance.	12 weeks

Trial Locations

Locations (4)

Clinic, Bhavnagar, Rajivoza59@hotmail.com; 🇮🇳 Bhavnagar, GUJARAT, India

KEM Hospital, Mumbai, pkirtic@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

NHL Medical College & Hospital, Ahmedabad, Rajpurvi@yahoo.com; 🇮🇳 Ahmadabad, GUJARAT, India

R. N. Cooper Hospital, Vileparle west, Mumbai, nitinmr@yahoo.in; 🇮🇳 Mumbai, MAHARASHTRA, India

Clinic, Bhavnagar, Rajivoza59@hotmail.com

🇮🇳Bhavnagar, GUJARAT, India

Dr. Rajiv R Oza

Principal investigator

Rajivoza59@hotmail.com