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

Phase 4

Completed

• Conditions: Dyslipidemia; Hypertension
• Interventions: Drug: Telmisartan; Drug: Duowell®

• Registration Number: NCT03267329
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-30
• Study Start: 2017-09-11
• Status Verified: 2020-05
• Primary Completion: 2020-09-02
• Study Completion: 2020-09-02
• Last Update Submitted: 2021-04-04
• Last Update Posted: 2021-04-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Telmisartan	Telmisartan	Once daily during 16 wks
Duowell® Tab.	Duowell®	Once daily during 16 wks

Primary Outcome Measures

Name	Time	Method
Changes from baseline in mean central systolic blood pressure	at week 16

Secondary Outcome Measures

Name	Time	Method
Changes from baseline in mean brachial systolic blood pressure	at week 4 and at week 16 and at week 28
Changes from baseline in carotid femoral pulse wave velocity	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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of