A Multicentre, Comparative, Controlled, Open Label, Randomized, Parallel Group, Phase III Study to Evaluate the Safety and Efficacy of Fixed Dose Combination Containing Rosuvastatin Calcium with Amlodipine Besylate versus Monotherapy for Stage 1 and Stage 2 Hypertension in Dyslipidemic Patients.

Biocon Limited0 个研究点目标入组 330 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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).

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