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

• Sponsor: Yuhan Corporation (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03267329
• Collaborator: (none)
• Enrollment: 80
• Location: 1
• Arms: 2
• Actual Duration (Months): 35.7
• Patients Per Site Per Month: 2.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hypertension; Dyslipidemia	Drug: Duowell®; Drug: Telmisartan	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: Sep 11, 2017
• Actual Primary Completion Date: Sep 2, 2020
• Actual Study Completion Date: Sep 2, 2020

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes from baseline in mean central systolic blood pressure [at week 16]

Secondary Outcome Measures

1. Changes from baseline in mean brachial systolic blood pressure [at week 4 and at week 16 and at week 28]

2. Changes from baseline in mean brachial pulse pressure [at week 4 and at week 16 and and at week 28]

3. Changes from mean brachial diastolic blood pressure [at week 4 and at week 16 and at week 28]

4. Changes from baseline in augmentation index [at week 16 and at week 28]

5. Changes from baseline in carotid femoral pulse wave velocity [at week 16 and at week 28]

Other Outcome Measures

1. 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]

2. Drug compliance between over 50% and less 50% of assessment in mobile application [at week 4 weeks and at week 16]

3. Drug compliance between over 50% and less 50% of assessment in mobile application [up to 3 months end of study]

4. Changes from the end of treatment in central systolic blood pressure after 3 months [at 3 months from the end of study]

5. Numbers of inconvenience reported by mobile application at each visit [up to 16 weeks]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Hospital	Seoul		Korea, Republic of

Sponsors and Collaborators

• Yuhan Corporation

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yuhan Corporation
• ClinicalTrials.gov Identifier: NCT03267329
• Other Study ID Numbers: YMC023
• First Posted: Aug 30, 2017
• Last Update Posted: Apr 6, 2021
• Last Verified: May 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Hypertension; Dyslipidemias; Telmisartan

Study Results

No Results Posted as of Apr 6, 2021