NCT02294539

Brief Summary

The purpose of this study is to investigate which combination therapy is more effective for improving the blood pressure (BP) and AM central SBP in hypertensive patients:Angiotensin II receptor blocker (ARB) plus calcium channel blocker (CCB) or ARB plus diuretics

Trial Health

87
On Track

Trial Health Score

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

Enrollment
231

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Aug 2014

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

August 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 12, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

November 19, 2014

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 18, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 18, 2016

Completed
Last Updated

March 15, 2017

Status Verified

March 1, 2017

Enrollment Period

1.8 years

First QC Date

November 12, 2014

Last Update Submit

March 14, 2017

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • change from baseline in msSBP

    4 weeks

Secondary Outcomes (1)

  • change from baseline in AMcSBP

    20 weeks

Study Arms (4)

Losartan 50mg/amlodipine 5mg

EXPERIMENTAL

Once daily, 1T, PO medication

Drug: Losartan 50mg/Hydrochlorothiazide 12.5mg

Losartan 100mg/amlodipine 5mg

EXPERIMENTAL

Once daily, 1T, PO medication

Drug: Losartan 100mg/Hydrochlorothiazide 25mg

Losartan50 mg/Hydrochlorothiazide12.5 mg

ACTIVE COMPARATOR

Once daily, 1T, PO medication

Drug: Losartan 50mg/amlodipine 5mg

Losartan100 mg/Hydrochlorothiazide25 mg

ACTIVE COMPARATOR

Once daily, 1T, PO medication

Drug: Losartan 100mg/amlodipine 5mg

Interventions

Losartan 50mg/amlodipine 5mgDRUG

once daily, 1T, PO medication

Also known as: amosartan 5/50mg
Losartan50 mg/Hydrochlorothiazide12.5 mg
Losartan 100mg/amlodipine 5mgDRUG

once daily, 1T, PO medication

Also known as: amosartan 5/100mg
Losartan100 mg/Hydrochlorothiazide25 mg
Losartan 50mg/Hydrochlorothiazide 12.5mgDRUG

once daily, 1T, PO medication

Also known as: Cozaar Plus
Losartan 50mg/amlodipine 5mg
Losartan 100mg/Hydrochlorothiazide 25mgDRUG

once daily, 1T, PO medication

Also known as: Cozaar Plus F
Losartan 100mg/amlodipine 5mg

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Mean seated SBP ≥140mmHg in patients with newly Diagnosed
  • \- msDBP≥110mmHg or ms SBP ≥ 180mmHg at the screening and randomization visit

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Related Publications (2)

  • Cho EJ, Lee HY, Sung KC, Park S, Sohn IS, Park CG, Choi DJ, Ha JW, Ahn YK, Shin J, Hong SJ, Kim SK, Chung WJ, Yoo BS, Hong TJ, Youn HJ, Cho MC, Chae SC, Kim YJ, Kim CJ. Comparison of 24-Hour Ambulatory Central Blood Pressure Reduction Efficacy Between Fixed Amlodipine or Up-Titrated Hydrochlorothiazide Plus Losartan: The K-Central Study. Am J Hypertens. 2019 Sep 24;32(10):992-1002. doi: 10.1093/ajh/hpz050.

    PMID: 31099387DERIVED

  • Oh GC, Lee HY, Chung WJ, Youn HJ, Cho EJ, Sung KC, Chae SC, Yoo BS, Park CG, Hong SJ, Kim YK, Hong TJ, Choi DJ, Hyun MS, Ha JW, Kim YJ, Ahn Y, Cho MC, Kim SG, Shin J, Park S, Sohn IS, Kim CJ. Comparison of effects between calcium channel blocker and diuretics in combination with angiotensin II receptor blocker on 24-h central blood pressure and vascular hemodynamic parameters in hypertensive patients: study design for a multicenter, double-blinded, active-controlled, phase 4, randomized trial. Clin Hypertens. 2017 Sep 4;23:18. doi: 10.1186/s40885-017-0074-0. eCollection 2017.

    PMID: 28879040DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

LosartanAmlodipineHydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDihydropyridinesPyridinesChlorothiazideBenzothiadiazinesSulfonamidesSulfonesSulfur CompoundsThiazidesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Chong-Jin Kim

    Kyung Hee University Hospital at Gangdong

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Chairman of Cardiovascular Center

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 19, 2014

Study Start

August 1, 2014

Primary Completion

May 18, 2016

Study Completion

May 18, 2016

Last Updated

March 15, 2017

Record last verified: 2017-03

Locations

KR(1)