Duowell® vs. Telmisartan Monotherapy in Mild Dyslipidemia Patients With Hypertension

NCT ID: NCT03267329

Last Updated: 2021-04-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2020-09-02

Brief Summary

This study is to evaluate effect and safety on central blood pressure with Duowell compared to telmisartan monotherapy in mild dyslipidemia patients with hypertension during 16 weeks.

Conditions

Hypertension; Dyslipidemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Duowell® Tab.

Once daily during 16 wks

Group Type: EXPERIMENTAL

Duowell®

Intervention Type: DRUG

telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%\~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%

Telmisartan

Once daily during 16 wks

Group Type: ACTIVE_COMPARATOR

Telmisartan

Intervention Type: DRUG

telmisartan 80mg

Interventions

Duowell®

telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%\~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%

Intervention Type: DRUG

Telmisartan

telmisartan 80mg

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 40 to 75 years old diagnosed with hypertension
• at screening, SBP ≥ 140 mmHg
• at randomization, 130 mmHg ≤ SBP ≤160 mmHg or 80 mmHg ≤ DBP ≤ 100 mmHg
• at screening, ASCVD risk ≥ 5 %
• Those who did not take the dyslipidemic medications during screening or who stopped medication for more than 2 months
• at screening, 130 mg/dL ≤ Calculated (or Measured) Serum LDL-C ≤ 190 mg/dL
• Pregnancy test negative and and who has agreed to perform effective contraception during the clinical trial

Exclusion Criteria

• known hypersensitivity to AT-1 receptor blockers or statins
• Those who are treated with secondary hypertension during screening
• Those who are being treated for malignant hypertension during screening
• Those who are taking concurrent medication that may affect blood pressure during screening
• Those who have been diagnosed with myocardial infarction or unstable angina or stroke within the last 6 months at screening
• Patients with heart failure NYHA III-IV or Left Ventricular Ejection Fraction <40% within the last 6 months at screening
• Patients with valve disease with hemodynamically significant (over moderate degree) obstructive
• Those with known atrial fibrillation or atrioventricular conduction disturbance
• Those who show the following numerical values during the screening test

1. CPK ≥ 3 times the normal upper limit

2. Serum Creatinine > 3 mg/dL

3. Serum Potassium > 5.5 mmol/L

4. ALT or AST ≥ 3 times the upper normal limit

• Those with known bilateral renal artery stenosis
• Patients who underwent open heart surgery within 4 weeks prior to randomization and who had a cardiac surgery plan
• Those taking statins within 8 weeks before randomization
• Those with severe obstructive, limited or other pulmonary disease history
• Those with non-cardiac disease that can significantly shorten the expected life span to less than 2 years (eg, severe cancer)
• at screening, Anti-HIV Ab, HBsAg, HCV Ab positive

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Yuhan Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

YMC023

Identifier Type: -

Identifier Source: org_study_id