Efficacy and Safety of Telmisartan/Rosuvastatin Co-administration in Hypertensive Patients With Hyperlipidemia
Phase 3
- Conditions
- HypertensionHyperlipidemia
- Interventions
- Registration Number
- NCT02087540
- Lead Sponsor
- IlDong Pharmaceutical Co Ltd
- Brief Summary
To identify efficacy and safety of Telmisartan/Rosuvastatin co-administration in hyperlipidemia control in hypertensive patients with hyperlipidemia compared to each monotherapy.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 310
Inclusion Criteria
- Signed Informed Consent
- Men and women >18 years of age
- Subject who has one of 3 conditions classifed by Cardiovascular Risk Factors, 10-Year Risk, Blood Pressure, LDL-C, Coronary Artery Disease and Equivalent
Exclusion Criteria
- Female who are pregnant, breastfeeding, or of childbearing potential, unwilling to practice adequate contraception throughout the study,.
- Other exclusions applied
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Telmisartan 80mg & Rosuvastatin placebo Telmisartan 80mg PO, Once Daily, 8 weeks Telmisartan placebo & Rosuvastatin 20mg Rosuvastatin 20mg PO, Once Daily, 8 weeks Telmisartan placebo & Rosuvastatin 20mg Placebo(for Rosuvastatin 10mg) PO, Once Daily, 8 weeks Telmisartan Placebo & Rosuvastatin 10mg Rosuvastatin 10mg PO, Once Daily, 8 weeks Telmisartan Placebo & Rosuvastatin 10mg Placebo(for Telmisartan 80mg) PO, Once Daily, 8 weeks Telmisartan Placebo & Rosuvastatin 10mg Placebo(for Rosuvastatin 20mg) PO, Once Daily, 8 weeks Telmisartan 80mg & Rosuvastatin 10mg Telmisartan 80mg PO, Once Daily, 8weeks Telmisartan 80mg & Rosuvastatin 10mg Rosuvastatin 10mg PO, Once Daily, 8weeks Telmisartan 80mg & Rosuvastatin 20mg Telmisartan 80mg PO, Once Daily, 8 weeks Telmisartan 80mg & Rosuvastatin 20mg Rosuvastatin 20mg PO, Once Daily, 8 weeks Telmisartan 80mg & Rosuvastatin 20mg Placebo(for Rosuvastatin 10mg) PO, Once Daily, 8 weeks Telmisartan 80mg & Rosuvastatin placebo Placebo(for Rosuvastatin 20mg) PO, Once Daily, 8 weeks Telmisartan placebo & Rosuvastatin placebo Placebo(for Telmisartan 80mg) PO, Once Daily, 8 weeks Telmisartan placebo & Rosuvastatin placebo Placebo(for Rosuvastatin 20mg) PO, Once Daily, 8 weeks Telmisartan placebo & Rosuvastatin 20mg Placebo(for Telmisartan 80mg) PO, Once Daily, 8 weeks Telmisartan 80mg & Rosuvastatin 10mg Placebo(for Rosuvastatin 20mg) PO, Once Daily, 8weeks Telmisartan 80mg & Rosuvastatin placebo Placebo(for Telmisartan 80mg) PO, Once Daily, 8 weeks Telmisartan placebo & Rosuvastatin placebo Placebo(for Rosuvastatin 10mg) PO, Once Daily, 8 weeks
- Primary Outcome Measures
Name Time Method •Change in seated diastolicblood pressure at 8 weeks compared to the base value at the 8 weeks Change in LDL-Cat 8 weeks compared to the base value (% change) at the 8 weeks
- Secondary Outcome Measures
Name Time Method Change in seateddiastolic blood pressure at 2,4 8 weeks Change in seated systolic blood pressure at 2,4,8weeks Rate of patients achieving a therapeutic purpose according to JNC VII Guideline [therapeutic purpose for blood pressure: < 140/90 mmHg (however, < 130/80 mmHg for Group III)] at 2, 4 and 8 weeks Change in LDL-Cat compared to the base value (% change) 2, 4 and 8 weeks Change in TC, TG, HDL-C and Apolipoprotein B compared to the base value (% change) at 2, 4 and 8 weeks Rate of patients achieving a therapeutic purpose according to NCEP ATP III Guideline therapeutic purpose for LDL-C- (Group I: < 160 mg/dL, Group II: < 130 mg/dL, Group III: < 100 mg/dL) at 2, 4 and 8 weeks
Trial Locations
- Locations (1)
The Catholic University of Saint Mary's Hosiptal
đŸ‡°đŸ‡·Seoul, Korea, Republic of