Health Condition 1: null- patients with essential hypertension coexisting with hyperlipidemia
Conditions
Interventions
Intervention1: S-Metoprolol,Atorvastatin,Ramipril: S-Metoprolol-25/50 mg,Atorvastatin-10mg and Ramipril 5mg given orally once daily for 12 weeks.
Control Intervention1: NIL: NIL
Sponsors
Emcure Pharmaceuticals Ltd Pune
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
India
Contacts
Public ContactDr Anand V Tendulkar
Outcome results
None listed