Evaluation of the efficacy and safety of a fixed dose combination of Rosuvastatin Calcium and Telmisartan with monotherapy of Rosuvastatin Calcium or Telmisartan on Mild to Moderate high blood pressure patients with high cholesterol.
- Conditions
- Health Condition 1: null- Dyslipidemic patients with mild to moderate hypertension
- Registration Number
- CTRI/2012/01/002340
- Lead Sponsor
- Biocon Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
ï??Male and female patients in the age group of 20-80 years
ï??Females of childbearing potential should have a negative pregnancy test at the prestudy visit and agree to use contraception during the study.
ï??Patients willing to give informed consent.
ï??Mild to moderate primary type hypertensive patient.
ï??Any patient with hypercholesterolemia (with Non-HDL-C) who has above target goal according to NCEP-ATP III after 3 months of treatment with conventional statin doses, e.g. simvastatin 10-40 mg, atorvastatin 10-40 mg or rosuvastatin 5-20 mg.
ï??Patients who are willing to comply with all study requirements
ï??Patients who are unlikely to comply with protocol requirements (e.g., non-cooperative behavior, inability to attend the required by the protocol visits).
ï??Patients who are currently participating or had participated in other interventional study for last 3 months prior to their enrolment.
ï??Women who are pregnant, breast feeding or have the intention of becoming pregnant during their participation in the study.
ï??Women of childbearing potential who are not using effective and medically acceptable methods of contraception.
ï??Patients who are meeting any of the contraindications of the study medication according to the approved SPC.
ï??Secondary type of hypertensive patients.
ï??Known CVD, triglycerides > 500 mg/dL, renal disease (serum creatinine levels > 1.6 mg/dL), hypothyroidism [thyroid stimulating hormone (TSH) > 5 IU/mL], liver disease (ALT and/or AST levels > 3-fold upper limit of normal in more than 2 consecutive measurements), alcohol consumption > 3 drinks/day for men and > 2 drinks/day for women, and current or previous gout.
ï??Patients with diabetes will be included in the study if they are adequately controlled (HbA1c <7%) with one or 2 antidiabetic drugs (no change in their treatment will be made during the study period).
ï??Patients with hypertension will be included in the study if they are on stable medication for at least 3 months and their blood pressure is adequately controlled (no change in their treatment will be made during the study period).
ï??Patients currently taking lipid-lowering drugs (other than statins at a conventional dose) or having stopped them less than 4 weeks before study entry will be excluded.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate decrease in the blood pressure of hypertensive patients with LDL-C lowering efficacy of telmisartan 40 mg, or rosuvastatin 10 mg monotherapy with fixed dose combinations of telmisartan (40/20 mg) and rosuvastatin (20/10/5 mg).Timepoint: 10 weeks
- Secondary Outcome Measures
Name Time Method To assess and compare the effects of telmisartan (40/20 mg) in combination with rosuvastatin (20/10/5 mg) vs. monotherapy of rosuvastatin 10 mg and telmisertan 40 mg on percentage change of LDL-C, HDL-C, total cholesterol (TC), TG, non-HDL-C, TC/HDL-C, LDL-C/HDL-C, nonHDL-C/HDL-C and high sensitivity C-reactive protein (hs-CRP) from baseline after 10 weeks combination therapy.Timepoint: 10 weeks