The Efficacy and Safety of Triple Therapy 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

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

304 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-06-01

Brief Summary

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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.

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Detailed Description

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Patients were randomly assigned to 2 groups: (1) Triple therapy (40mg of telmisartan and 5mg of amlodipine and 10mg of rosuvastatin); (2) Dual therapy (5mg of amlodipine and 10mg of atorvastatin). After 8 weeks of treatment, the change in mean sitting systolic blood pressure (MSSBP) and the percent change in LDL-C between 2 group, will be compared.

Conditions

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Hypertension Dyslipidemias

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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NEWSTATIN TS

Triple therapy (Telmisartan + Amlodipine + Rosuvastatin 40/5/10mg)

Group Type ACTIVE_COMPARATOR

NEWSTATIN TS

Intervention Type DRUG

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks

CADUET

Dual therapy (Amlodipine + Atorvastatin 5/10mg)

Group Type PLACEBO_COMPARATOR

CADUET

Intervention Type DRUG

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks

Interventions

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NEWSTATIN TS

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with triple therapy (Newstatin TS 40/5/10mg) ; 1 tab qd for 8 weeks

Intervention Type DRUG

CADUET

Wash out/run in period with Amlodipine 5mg for 6 weeks and then treatment with dual therapy (Caduet 5/10mg) ; 1 tab qd for 8 weeks

Intervention Type DRUG

Other Intervention Names

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Newstatin TS 40/5/10mg Caduet 5/10mg

Eligibility Criteria

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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.

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No