The Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin

A Multi-center, Randomized, Parallel Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension

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.

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.

Inclusion Criteria:

• 145 mmHg ≤ msSBP ≤ 190 mmHg
• Triglycerides < 500 mg/dL
• LDL-C ≤ 250 mg/dL

Exclusion Criteria:

• 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.