The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin
- Registration Number
- NCT03860220
- Lead Sponsor
- Hyo-Soo Kim
- Brief Summary
The goal of this study was to assess the efficacy and safety of FDC therapy with triple therapy of Telmisartan 40 mg/Amlodipine 5 mg/Rosuvastatin 10mg in Korean patients with both hypertension and dyslipidemia.
- Detailed Description
Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 304
- 145 mmHg ≤ msSBP ≤ 190 mmHg
- Triglycerides < 500 mg/dL
- LDL-C ≤ 250 mg/dL
- sSBP ≥ 20mmHg and sDBP ≥ 10mmHg
- symptomatic orthostatic hypotension and secondary/iatrogenic hypertension and dyslipidemia
- history of moderate to severe cerebral ischemia, cerebral hemorrhage, transient ischemic attack, myocardial infarction, or unstable angina in the past 6 months; severe heart failure (New York Heart Association functional class III and IV)
- hypersensitivity to telmisartan or rosuvastatin
- history of angioedema after treatment with angiotensin-converting enzyme inhibitors or ARBs; creatinine phosphokinase levels ≥3 times the upper limit of normal
- estimated glomerular filtration rate ≤30 mL/min; aspartate aminotransferase and alanine aminotransferase levels ≥3 times the upper limit of normal
- potassium levels >5.5 mmol/L; or any diseases that could affect the results of the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NEWSTATIN TS NEWSTATIN TS Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg) CADUET CADUET Dual therapy (Amlodipine + Atorvastatin 5/10mg)
- Primary Outcome Measures
Name Time Method Percent changes in LDL-C 8 weeks Percent changes in LDL-C from baseline after 8 weeks of treatment
Percent changes in mean sitting systolic blood pressure (MSSBP) 8 weeks Percent changes in MSSBP from baseline after 8 weeks of treatment
- Secondary Outcome Measures
Name Time Method Percent changes in TG 4, 8weeks Percent changes in TG from baseline after 4 and 8 weeks of treatment
Percent changes in LDL-C 4 weeks Percent changes in LDL-C from baseline after 4 weeks of treatment
Percent changes in HDL-C 4, 8weeks Percent changes in HDL-C from baseline after 4 and 8 weeks of treatment
Percent changes in Non-HDL-C 4, 8weeks Percent changes in Non-HDL-C from baseline after 4 and 8 weeks of treatement
Percent changes in Apo B 4, 8weeks Percent changes in Apo B from baseline after 4 and 8 weeks of treatment
Percent changes in hs-CRP 4, 8weeks Percent changes in hs-CRP from baseline after 4 and 8 weeks of treatment
Changes in mean sitting systolic/diastolic blood pressure 4, 8weeks Changes in mean sitting systolic/diastolic blood pressure after 4 and 8 weeks of treatment
Percent changes in TC 4, 8weeks Percent changes in TC from baseline after 4 and 8 weeks of treatment
Percent changes in Apo A-I 4, 8weeks Percent changes in Apo A-I from baseline after 4 and 8 weeks of treatment
Percent changes in LDL-C/HDL-C ratio 4, 8weeks Percent changes in LDL-C/HDL-C from baseline after 4 and 8 weeks of treatement
Percent changes in Apo B/Apo A-I ratio 4, 8weeks Percent changes in Apo B/Apo A-I from baseline after 4 and 8 weeks of treatment
The percentage of patients achieving treatment goal for blood pressure and LDL-C 8 weeks The percentage of patients achieving treatment goal for blood pressure and LDL-C