Clinical trial NCT04074551: A Phase 3 Study to Compare the Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
Official title: A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 Versus HCP1701 in Patients With Hypertension and Dyslipidemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Dyslipidemias
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2019-08-30
Enrollment: 145
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Randomized, Double-blinded, Multi-center, Phase III Study to Compare The Efficacy and Safety of Co-administered HGP0608, HGP0904 and HCP1306 versus HCP1701 in Patients with Hypertension and Dyslipidemia


Eligibility criteria: Inclusion Criteria:

* Age ≥ 19
* Patients who understood the contents and purpose of this trial and signed informed consent form
* Patients with essential hypertension and dyslipidemia

Exclusion Criteria:

* Patients with differences between arms greater than 20 mmHg for mean sitSBP or 10 mmHg for mean sitDBP
* Patients with mean sitSBP ≥ 180 mmHg or mean sitDBP ≥ 110 mmHg
* Concomitant administration of cyclosporine
* Tolerance or Hypersensitivity Angiotensin II receptor blocker or HMG-CoA reductase inhibitor, Calcium channel blocker(dihydropyridine) or Multi-drug allergy
* Hereditary angioedema or medical history of angioedema in the treatment of ACE inhibitors or angiotensin II receptor blockers
* Fibromyalgia, myopathy, rhabdomyolysis or acute myopathy or medical history of adverse effect to statin
* CPK normal range \> 2 times
* Secondary hypertension and suspected secondary hypertension
* Orthostatic hypotension with symptoms
* Uncontrolled primary hypothyroidism(TSH normal range ≥ 1.5 times)
* Severe hepatopathy or active hepatopathy (AST or ALT normal range ≥ 3 times)
* Active gout or hyperuricemia(uric acid ≥ 9mg/dL)
* IDDM or uncontrolled type 2 diabetes mellitus (HbA1c \> 9%)
* Ventricular arrhythmia
* Medical history

  * Severe heart disease(heart failure of NYHA class III-IV)
  * Severe cerebrovascular disease within 6 months (cerebral infarction, cerebral hemorrhage), hypertensive encephalopathy, transient cerebral ischemic attack(TIA)
  * Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant stenosis in aortic valve or mitral valve
  * Ischemic heart disease(myocardial infarction, angina) within 6months
  * Angioplasty or coronary artery bypass graft(CABG) surgery within 6months

Primary outcomes:
measure: Change from baseline in LDL-C (%)
timeFrame: baseline, 8 weeks
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 8 weeks
Secondary outcomes:
measure: Change from baseline in LDL-C (%)
timeFrame: baseline, 8 weeks
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 8 weeks
measure: Change from baseline in LDL-C (%)
timeFrame: baseline, 4 weeks
measure: Change from baseline in sitting systolic blood pressure
timeFrame: baseline, 4 weeks
measure: Change from baseline in TC, HDL-C, TG (%)
timeFrame: baseline, 4 weeks, 8 weeks
measure: Change from baseline in sitting distolic blood pressure
timeFrame: baseline, 4 weeks, 8 weeks
measure: Proportion of subject achieving LDL-C control
timeFrame: baseline, 4 weeks, 8 weeks
measure: Proportion of subjects achieving blood pressure control
timeFrame: baseline, 4 weeks, 8 weeks
measure: Proportion of responder for blood pressure
timeFrame: baseline, 4 weeks, 8 weeks
measure: Proportion of subject achieving both LDL-C and blood pressure control
timeFrame: baseline, 4 weeks, 8 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
state: Seoul-si
Study officials:
affiliation: Seoul National University Hospital
name: Hyo-Soo Kim, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: