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

A Multi-center, Randomized, Double-blind, Parellel Phase III Clinical Trial to Evaluate the Efficacy and Safety of Triple Therapy of Telmisartan/Amlodipine/Rosuvastatin in Patients With Dyslipidemia and Hypertension

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03088254

Enrollment

126

Registered

2017-03-23

Start date

2016-09-20

Completion date

2017-12-04

Last updated

2018-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dyslipidemia With Hypertension

Brief summary

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

Interventions

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

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

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

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

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
change of LDL-C	baseline and 8 weeks
change of msSBP	baseline and 8 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026