Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Rosuvastatin with Amlodipine for hypertension in Dyslipidemic Patients.
- Conditions
- Health Condition 1: null- Stage 1 and Stage 2 Hypertension in Dyslipidemic Patients.
- Registration Number
- CTRI/2012/02/002428
- Lead Sponsor
- Biocon Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 330
1.Patients willing to give informed consent
2.Male and female patients with stage 1 (SBP >=140 mmHg / DBP >=90 mm Hg- SBP 159mmHg / DBP 99 mm Hg) and stage 2 hypertension(SBP >=160 mmHg / DBP >=90 mm Hg- SBP 180mmHg / DBP >=110 mm Hg
3.Border line high (LDL value between 130-159) and high dyslipidemic (LDL values between 160-189)
4.Subjects aged 18 years and above
5.Patients with hypertension who are on stable medication for at least 3 months, but their blood pressure is not adequately controlled
6.Hypertensive patients who are not taking treatment or taking irregular treatment, and hypertensive patients who are not responding to the treatment; but not on amlodipine besylate
7.Patients who are willing to comply with all study requirements
8.Females of childbearing potential should have a negative pregnancy test at the pre study visit and agree to use contraception during the study.
1.Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
2.Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
3.Known CVD, triglycerides 500 mg/dL, renal disease (serum creatinine levels 1.6 mg/dL), hypothyroidism, liver disease (ALT and/or AST levels 3-fold upper limit of normal in more than 2 consecutive measurements),
4.Alcohol consumption 3 drinks/day for men and 2 drinks/day for women, and current or previous gout.
5.Patients with HbA1c >= 9%
6.Patients who are positive for HIV test.
7.Patients currently taking lipid-lowering drugs other than statins.
8.Patients with abnormal Creatine Kinase (CK) level ( 2.5 times the upper normal limit).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method â?¢The percentage of reduction in systolic and/or diastolic blood pressure from baseline with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs amlodipine besylate 5 mg monotherapy <br/ ><br>â?¢The percentage of reduction in LDL-C levels from baseline with fixed dose combination of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs rosuvastatin calcium 10 mg monotherapyTimepoint: 12 weeks (84 days) of therapy
- Secondary Outcome Measures
Name Time Method â?¢Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study period <br/ ><br>â?¢Clinically significant changes in vital signs. <br/ ><br>â?¢Clinically significant changes in routine laboratory parameters <br/ ><br>â?¢Clinical Significant changes in the ECG <br/ ><br>Timepoint: 12 weeks;â?¢The percentage of patients treated with FDC of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs monotherapy of amlodipine besylate 5mg, achieving recommended blood pressure levels <br/ ><br>â?¢The percentage of change in HDL-C, TC and fasting TG levels <br/ ><br>â?¢The percentage of patients treated with FDC of rosuvastatin calcium (5/10/20 mg) with amlodipine besylate (2.5/5/10 mg) vs. monotherapy of rosuvastatin calcium 10 mg, achieving LDL-C levels recommended by NCEP/ATP IIITimepoint: 12 weeks (84 days) of therapy