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

Jeil Pharmaceutical

Status and phase: Completed; Phase 3

Conditions: Dyslipidemia With Hypertension

Treatments: Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg); Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo); Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03088254

J-TAROS-RCT

Details and patient eligibility

About

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

Enrollment: 126 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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126 participants in 3 patient groups

Group I

Experimental group

Description:

Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin 20 mg for 8 weeks

Treatment:

Drug: Group I (Telmisartan 80 mg, Amlodipine 10 mg, Rosuvastatin 20 mg)

Group II

Active Comparator group

Description:

Treatment of Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo for 8 weeks

Treatment:

Drug: Group II (Telmisartan 80 mg, Amodipine 10 mg, Rosuvastatin placebo)

Group III

Active Comparator group

Description:

Treatment of Telmisartan 80 mg, Amodipine placebo, Rosuvastatin 20 mg for 8 weeks

Treatment:

Drug: Group III (Telmisartan 80 mg, Amlodipine placebo, Rosuvastatin 20 mg)