Clinical trial NCT03267329: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Dyslipidemia
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2017-08-30
Enrollment: 80
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

  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

Primary outcomes:
measure: Changes from baseline in mean central systolic blood pressure
timeFrame: at week 16
Secondary outcomes:
measure: Changes from baseline in mean brachial systolic blood pressure
timeFrame: at week 4 and at week 16 and at week 28
measure: Changes from baseline in mean brachial pulse pressure
timeFrame: at week 4 and at week 16 and and at week 28
measure: Changes from mean brachial diastolic blood pressure
timeFrame: at week 4 and at week 16 and at week 28
measure: Changes from baseline in augmentation index
timeFrame: at week 16 and at week 28
measure: Changes from baseline in carotid femoral pulse wave velocity
timeFrame: at week 16 and at week 28
Other outcomes:
measure: Changes from baseline in central blood pressure according to the frequency of access in mobile application
timeFrame: up to 4 weeks and up to 16 weeks
measure: Drug compliance between over 50% and less 50% of assessment in mobile application
timeFrame: at week 4 weeks and at week 16
measure: Drug compliance between over 50% and less 50% of assessment in mobile application
timeFrame: up to 3 months end of study
measure: Changes from the end of treatment in central systolic blood pressure after 3 months
timeFrame: at 3 months from the end of study
measure: Numbers of inconvenience reported by mobile application at each visit
timeFrame: up to 16 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References: