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

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03267329
• Other study ID #: YMC023
• Status: Completed
• Phase: Phase 4
• Start date: September 11, 2017
• Est. completion date: September 2, 2020

Study information

• Verified date: May 2020
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 2, 2020
• Est. primary completion date: September 2, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypertension

Intervention

Drug:
• Duowell®
telmisartan 80mg/rosuvastatin 10mg for ASCVD risk=5%~7.5% or telmisartan 80mg/rosuvastatin 20mg for ASCVD risk=7.5%
• Telmisartan
telmisartan 80mg

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Drug compliance between over 50% and less 50% of assessment in mobile application		at week 4 weeks and at week 16
Other	Drug compliance between over 50% and less 50% of assessment in mobile application		up to 3 months end of study
Other	Changes from the end of treatment in central systolic blood pressure after 3 months		at 3 months from the end of study
Other	Numbers of inconvenience reported by mobile application at each visit		up to 16 weeks
Primary	Changes from baseline in mean central systolic blood pressure		at week 16
Secondary	Changes from baseline in mean brachial systolic blood pressure		at week 4 and at week 16 and at week 28
Secondary	Changes from baseline in mean brachial pulse pressure		at week 4 and at week 16 and and at week 28
Secondary	Changes from mean brachial diastolic blood pressure		at week 4 and at week 16 and at week 28
Secondary	Changes from baseline in augmentation index		at week 16 and at week 28
Secondary	Changes from baseline in carotid femoral pulse wave velocity		at week 16 and at week 28