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

• Status: Unknown status
• Trial end date: 2020-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hyo-Soo Kim
• Treatments: Amlodipine; Amlodipine, atorvastatin drug combination; Rosuvastatin Calcium; Telmisartan

Criteria

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.