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

Primary Purpose

Hypertension, Dyslipidemia

Status

Completed

Phase

Phase 4

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Duowell®

Telmisartan

About this trial

This is an interventional treatment trial for Hypertension

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Seoul National University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Duowell® Tab.

Telmisartan

Arm Description

Once daily during 16 wks

Outcomes

Primary Outcome Measures

Changes from baseline in mean central systolic blood pressure

Secondary Outcome Measures

Changes from baseline in mean brachial systolic blood pressure

Changes from baseline in mean brachial pulse pressure

Changes from mean brachial diastolic blood pressure

Changes from baseline in augmentation index

Changes from baseline in carotid femoral pulse wave velocity

Full Information

NCT ID

NCT03267329

First Posted

August 28, 2017

Last Updated

April 4, 2021

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT03267329

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2020

Overall Recruitment Status

Completed

Study Start Date

September 11, 2017 (Actual)

Primary Completion Date

September 2, 2020 (Actual)

Study Completion Date

September 2, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypertension, Dyslipidemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

80 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Duowell® Tab.

Arm Type

Experimental

Arm Description

Once daily during 16 wks

Arm Title

Telmisartan

Arm Type

Active Comparator

Arm Description

Once daily during 16 wks

Intervention Type

Drug

Intervention Name(s)

Duowell®

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Telmisartan

Intervention Description

telmisartan 80mg

Primary Outcome Measure Information:

Title

Changes from baseline in mean central systolic blood pressure

Time Frame

at week 16

Secondary Outcome Measure Information:

Title

Changes from baseline in mean brachial systolic blood pressure

Time Frame

at week 4 and at week 16 and at week 28

Title

Changes from baseline in mean brachial pulse pressure

Time Frame

at week 4 and at week 16 and and at week 28

Title

Changes from mean brachial diastolic blood pressure

Time Frame

at week 4 and at week 16 and at week 28

Title

Changes from baseline in augmentation index

Time Frame

at week 16 and at week 28

Title

Changes from baseline in carotid femoral pulse wave velocity

Time Frame

at week 16 and at week 28

Other Pre-specified Outcome Measures:

Title

Changes from baseline in central blood pressure according to the frequency of access in mobile application

Time Frame

up to 4 weeks and up to 16 weeks

Title

Drug compliance between over 50% and less 50% of assessment in mobile application

Time Frame

at week 4 weeks and at week 16

Title

Drug compliance between over 50% and less 50% of assessment in mobile application

Time Frame

up to 3 months end of study

Title

Changes from the end of treatment in central systolic blood pressure after 3 months

Time Frame

at 3 months from the end of study

Title

Numbers of inconvenience reported by mobile application at each visit

Time Frame

up to 16 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 CPK ≥ 3 times the normal upper limit Serum Creatinine > 3 mg/dL Serum Potassium > 5.5 mmol/L 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

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

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

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