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

Jeil Pharmaceutical Co., Ltd.126 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

126

Conditions

Dyslipidemia With Hypertension

Interventions

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

Twinstar(80/10 mg) and Rosuvastatin 20 mg for 8 weeks

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

Twinstar(80/10 mg) and Rosuvastatin placebo for 8 weeks

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

Twinstar placebo, Amlodipine 10 mg and Rosuvastatin 20 mg for 8 weeks

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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

Locations (12)

Chungnam National University Hospital

Daejeon, South Korea

Chonnam National University Hospital

Gwangju, South Korea

Seoul National University Bundang Hospital

Gyeonggi-do, South Korea

Outcomes

Primary Outcomes

change of LDL-C

Time frame: baseline and 8 weeks

change of msSBP

Time frame: baseline and 8 weeks

Data from ClinicalTrials.gov

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