Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Rosuvastatin with Amlodipine for hypertension in Dyslipidemic Patients.
- Conditions
- Stage 1 and Stage 2 Hypertension in Dyslipidemic Patients.
- Registration Number
- CTRI/2012/02/002428
- Lead Sponsor
- Biocon Limited
- Brief Summary
This is a multicentre, randomized, parallel-group, open label study to compare the safety and efficacy of FDC containing rosuvastatin calcium and amlodipine besylate on stage 1 and stage 2 hypertension with dyslipidemic patients with that of monotherapy. There are 11 treatment arms planned for this study, 9 fixed dose combination arms of rosuvastatin calcium (5/10/20 mg/day) + amlodipine besylate (2.5/5/10 mg/day) and two monotherapy arms of rosuvastatin calcium (10 mg/day) and amlodipine besylate (5 mg/day). The study is planned to enroll a total of 330 patients; 30 patients in each arm.Patients will be stratified based on the SBP/DBP and LDL-C levels and randomized within each stratum with equal proportion to any of the treatment arms within the stratum.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other
- Sex
- All
- 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 •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 12 weeks (84 days) of therapy •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 monotherapy 12 weeks (84 days) of therapy
- Secondary Outcome Measures
Name Time Method •Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study period •Clinically significant changes in vital signs. •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 •The percentage of change in HDL-C, TC and fasting TG levels
Trial Locations
- Locations (6)
Belgaum Diabetic Center
🇮🇳Belgaum, KARNATAKA, India
Dr. B.R.Ambedkar Medical College
🇮🇳Bangalore, KARNATAKA, India
Jawaharlal Nehru Medical College and KLES Dr Prabhakar kore Hospital and Medical research centre
🇮🇳Belgaum, KARNATAKA, India
KIMS Hospital
🇮🇳Bangalore, KARNATAKA, India
Meenakshi Mission Hospital & Research Center
🇮🇳Madurai, TAMIL NADU, India
Sapthagiri Institute of Medical Sciences and Research Center
🇮🇳Bangalore, KARNATAKA, India
Belgaum Diabetic Center🇮🇳Belgaum, KARNATAKA, IndiaDr Neeta DeshpandePrincipal investigator09880271313neetarohit@gmail.com