Clinical Trial of S-Metoprolol , Atorvastatin and Ramipril combination tablet in the treatment of Hypertensio
- Conditions
- Health Condition 1: null- patients with essential hypertension coexisting with hyperlipidemia
- Registration Number
- CTRI/2011/06/001818
- Lead Sponsor
- Emcure Pharmaceuticals Ltd Pune
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Subjects diagnosed with essential hypertension not controlled on monotherapy or newly diagnosed Stage II hypertensives, Patients with serum LDL-C level more than or equal to 130 mg/dL and triglyceride Level lesser than or equal to 350
mg/dL,Subject willing to give written informed consent and willing to comply with study protocol
Subjects previously sensitive to any of the ingredients of the fixed dose combination under study or beta blockers or statins or angiotensin receptor blockers, Subjects with history of secondary or malignant hypertension, Patients with significant known respiratory/liver/kidney/neurological diseases / uncontrolled diabetes, Patients with any evidence of cardiac arrhythmia on ECG, Known history of myopathy or rhabdomyolysis with statins, Pregnant and lactating women or the women of child bearing age who are not practicing the effective means of contraception,Patients who will receive some other drug during the study besides that in the protocol that could alter the pharmacokinetic/ pharmacodynamic profile of the study drug, Patients with alcohol or drug abuse, Any condition that, in the opinion of the investigator, does not justify the patient?s inclusion in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportation of patients with decrease in diastolic blood pressure by atleast 10 mm hg compared to baseline at the end of study.Timepoint: After 12 weeks
- Secondary Outcome Measures
Name Time Method Compliance of TherapyTimepoint: After 4, 8 and 12 weeks;Mean change in LDL-C Levels as compared to BaselineTimepoint: After 12 weeks;Mean change in total cholesterol, HDL and triglycerides as compared to baselineTimepoint: After 12 weeks;Mean reduction in heart rate compared to baselineTimepoint: After 4, 8 and 12 weeks;Mean reduction in Systolic and Diastolic Blood pressure compared to baselineTimepoint: After 4, 8 and 12 weeks;Percent of subjects experiencing any drug related adverse events as evaluated and recorded by the investigatorTimepoint: After 4, 8 and 12 weeks;Subjects as well as Physicians global assessment about tolerability of drugsTimepoint: After 12 weeks