Study to Evaluate the Efficacy and Safety of Telmisartan/Amlodipine/Rosuvastatin

• Status: Completed
• Trial end date: 2017-12-04
• Target enrollment: 0
• Participant gender: All

Summary

To evaluate efficacy and safety of co-administrated temisartan/amlodipine and rosuvastatin in subjects with dyslipidemia with hypertension.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeil Pharmaceutical Co., Ltd.
• Treatments: Amlodipine; Rosuvastatin Calcium; Telmisartan

Criteria

Inclusion Criteria:

• Dyslipidemia with hypertesion

• msSBP < 180 mmHg

• msDBP < 110 mmHg

• LDL-C ≤ 250 mg/dL

• Triglycerides < 400 mg/dL

Exclusion Criteria:

• At Visit 3, BP difference SBP ≥20mmHg or DBP ≥10mmHg

• CK normal range ≥ 2 times

• Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)

• AST or ALT ≥ 2 times

• Uncontrolled diabetes mellitus (HbA1c≥9%)

• CLcr < 30 mL/min/1.73m^2

• K > 5.5 mEq/L

• Other exclusion applied