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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-20

Study Completion Date

2017-12-04

Brief Summary

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

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Detailed Description

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Conditions

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Dyslipidemia With Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Group I

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Group II

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Group III

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No