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

A Randomized, Open, Parallel, Multicenter, Phase 4 Study to Evaluate the Central Aortic Pressure Effect Between Fixed Dose Combination (Duowell® Tab) and Monotherapy of Telmisartan in Mild Dyslipidemia Patients With Hypertension

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Dyslipidemia
• Intervention / Treatment: Drug: Duowell®; Drug: Telmisartan

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria (All of the followings)

• 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 (Any of the followings)

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Duowell® Tab.; Once daily during 16 wks	Drug: Duowell®; telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk≥7.5%
Active Comparator: Telmisartan; Once daily during 16 wks	Drug: Telmisartan; telmisartan 80mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in mean central systolic blood pressure	at week 16

Secondary Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in mean brachial systolic blood pressure	at week 4 and at week 16 and at week 28
Changes from baseline in mean brachial pulse pressure	at week 4 and at week 16 and and at week 28
Changes from mean brachial diastolic blood pressure	at week 4 and at week 16 and at week 28
Changes from baseline in augmentation index	at week 16 and at week 28
Changes from baseline in carotid femoral pulse wave velocity	at week 16 and at week 28

Other Outcome Measures

Outcome Measure	Time Frame
Changes from baseline in central blood pressure according to the frequency of access in mobile application	up to 4 weeks and up to 16 weeks
Drug compliance between over 50% and less 50% of assessment in mobile application	at week 4 weeks and at week 16
Drug compliance between over 50% and less 50% of assessment in mobile application	up to 3 months end of study
Changes from the end of treatment in central systolic blood pressure after 3 months	at 3 months from the end of study
Numbers of inconvenience reported by mobile application at each visit	up to 16 weeks

Collaborators and Investigators

• Sponsor: Yuhan Corporation

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): September 2, 2020
• Study Completion (Actual): September 2, 2020

Study Registration Dates

• First Submitted: August 28, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 30, 2017

Study Record Updates

• Last Update Posted (Actual): April 6, 2021
• Last Update Submitted That Met QC Criteria: April 4, 2021
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hypertension; Dyslipidemias; Molecular Mechanisms of Pharmacological Action; Antihypertensive Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists; Telmisartan
• Other Study ID Numbers: YMC023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No