NCT04074551

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
145

participants targeted

Target at P25-P50 for phase_3 hypertension

Timeline
Completed

Started Jul 2019

Shorter than P25 for phase_3 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 16, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 29, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 30, 2019

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 17, 2020

Completed
Last Updated

November 30, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

August 29, 2019

Last Update Submit

November 26, 2020

Conditions

HypertensionDyslipidemias

Outcome Measures

Primary Outcomes (2)

  • Change from baseline in LDL-C (%)

    Experimental, Active Control 1

    baseline, 8 weeks

  • Change from baseline in sitting systolic blood pressure

    Experimental, Active Control 2

    baseline, 8 weeks

Secondary Outcomes (10)

  • Change from baseline in LDL-C (%)

    baseline, 8 weeks

  • Change from baseline in sitting systolic blood pressure

    baseline, 8 weeks

  • Change from baseline in LDL-C (%)

    baseline, 4 weeks

  • Change from baseline in sitting systolic blood pressure

    baseline, 4 weeks

  • Change from baseline in TC, HDL-C, TG (%)

    baseline, 4 weeks, 8 weeks

  • +5 more secondary outcomes

Study Arms (3)

Experimental

EXPERIMENTAL

HCP1701

Drug: HCP1701

Active Comparator 1

ACTIVE COMPARATOR

HGP0904, HGP0608

Drug: LosartanDrug: Amlodipine

Active Comparator 2

ACTIVE COMPARATOR

HGP0608, HCP1306

Drug: LosartanDrug: Rosuvastatin and Ezetimibe

Interventions

HCP1701DRUG

HCP1701

Experimental
LosartanDRUG

Losartan

Active Comparator 1Active Comparator 2
AmlodipineDRUG

Amlodipine

Active Comparator 1
Rosuvastatin and EzetimibeDRUG

Rosuvastatin and Ezetimibe

Active Comparator 2

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 03080, South Korea

Location

Related Publications (1)

  • Kim MC, Ahn Y, Kim MH, Kim SY, Hong TJ, Rhee MY, Kim SH, Hong SJ, Kim H, Kim W, Chae IH, Kang DH, Kim BK, Kim HS. A Randomized, Multicenter, Double-blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a Quadruple Combination of Amlodipine, Losartan, Rosuvastatin, and Ezetimibe in Patients with Concomitant Essential Hypertension and Dyslipidemia. Am J Cardiovasc Drugs. 2023 Jul;23(4):441-454. doi: 10.1007/s40256-023-00590-9. Epub 2023 Jul 3.

    PMID: 37395974DERIVED

MeSH Terms

Conditions

HypertensionDyslipidemias

Interventions

LosartanAmlodipineRosuvastatin CalciumEzetimibe

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDihydropyridinesPyridinesSulfonamidesAmidesFluorobenzenesHydrocarbons, FluorinatedHydrocarbons, HalogenatedSulfonesSulfur CompoundsPyrimidinesAzetidinesAzetines

Study Officials

  • Hyo-Soo Kim, M.D., Ph.D

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 29, 2019

First Posted

August 30, 2019

Study Start

July 16, 2019

Primary Completion

March 17, 2020

Study Completion

March 17, 2020

Last Updated

November 30, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)