Health Condition 1: null- Stage 1 and Stage 2 Hypertension in Dyslipidemic Patients.
Conditions
Interventions
Intervention1: FDC tablet of rosuvastatin calcium 5 mg + amlodipine besylate 2.5 mg: Administered orally once daily for 12 weeks
Intervention2: FDC tablet of rosuvastatin calcium 5 mg + amlodipine bes
Sponsors
Biocon Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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
| Measure | Time frame |
|---|---|
| â?¢Incidence of adverse events (AEs) and serious adverse events (SAEs) during the study period â?¢Clinically significant changes in vital signs. â?¢Clinically significant changes in routine laboratory parameters â?¢Clinical Significant changes in the ECG 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 â?¢The percentage of change in HDL-C, TC and fasting TG levels 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 | — |
Countries
India
Contacts
Public ContactDr Vanita Sabhahit
Outcome results
None listed