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

NCT03267329 | Completed Phase 4

• 1 other identifier: YMC023
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension; Dyslipidemia

Outcome Measures

Primary Outcomes (1)

• Changes from baseline in mean central systolic blood pressure

  at week 16

Secondary Outcomes (5)

• 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 Outcomes (5)

• 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

Study Arms (2)

Duowell® Tab.

EXPERIMENTAL

Once daily during 16 wks

Drug: Duowell®

Telmisartan

ACTIVE COMPARATOR

Once daily during 16 wks

Drug: Telmisartan

Interventions

Duowell® DRUG

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

Duowell® Tab.

Telmisartan DRUG

telmisartan 80mg

Telmisartan

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Yuhan Corporation: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Hypertension; Dyslipidemias

Interventions

Telmisartan

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2017
• First Posted: August 30, 2017
• Study Start: September 11, 2017
• Primary Completion: September 2, 2020
• Study Completion: September 2, 2020
• Last Updated: April 6, 2021

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)