NCT00492128

Brief Summary

The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
196

participants targeted

Target at P50-P75 for phase_4 hypertension

Timeline
Completed

Started Sep 2007

Typical duration for phase_4 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

First Submitted

Initial submission to the registry

June 26, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 27, 2007

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2007

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

January 30, 2015

Status Verified

January 1, 2015

Enrollment Period

1.7 years

First QC Date

June 26, 2007

Last Update Submit

January 28, 2015

Conditions

Hypertension

Keywords

hypertensionangiotensin receptor blockerdiureticcombination therapy

Outcome Measures

Primary Outcomes (1)

  • The change of systolic blood pressure

    three months

Secondary Outcomes (4)

  • The achievement rate of target blood pressure

    three months

  • The change of diastolic blood pressure

    three months

  • The change of blood pressure

    six months, nine months and one year

  • The achievement rate of target blood pressure

    six months, nine months and one year

Study Arms (2)

Losartan/hydrochlorothiazide

EXPERIMENTAL

Combination drug with losartan 50mg and hydrochlorothiazide 12.5mg

Drug: Losartan/amlodipine or losartan/hydrochlorothiazide

Losartan/amlodipine

ACTIVE COMPARATOR

Combination therapy with losartan 50mg and amlodopine 5mg

Drug: Losartan/amlodipine or losartan/hydrochlorothiazide

Interventions

Losartan/amlodipine or losartan/hydrochlorothiazideDRUG

Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.

Also known as: Preminent (Hyzaar)
Losartan/amlodipineLosartan/hydrochlorothiazide

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Under treatment of hypertension with ARB monotherapy for more than one month.
  • systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position.
  • In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position.

You may not qualify if:

  • uncontrolled hypertension (diastolic blood pressure \>120mmHg)
  • uncontrolled diabetes mellitus (HbA1c\>9.0%)
  • Acute myocardial infarction, stroke and other cardiovascular events within six months
  • The history of gout, or uric acid\>8.0mg/dl
  • Serum creatinine\>2.0mg/dl
  • sever liver dysfunction
  • Bilateral renovascular stenosis
  • secondary hypertension
  • malignant hypertension
  • uncontrolled arrhythmia
  • pregnancy or possibility of pregnancy
  • hypersensitivity to trial drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yokohama City University Graduate School of Medicine

Yokohama, Kanagawa, 236-0004, Japan

Location

MeSH Terms

Conditions

Hypertension

Interventions

LosartanAmlodipinehydrochlorothiazide, losartan drug combination

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Biphenyl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsTetrazolesDihydropyridinesPyridines

Study Officials

  • Satoshi Umemura, MD, PhD

    Yokohama City University Graduate School of Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 26, 2007

First Posted

June 27, 2007

Study Start

September 1, 2007

Primary Completion

May 1, 2009

Study Completion

August 1, 2010

Last Updated

January 30, 2015

Record last verified: 2015-01

Locations

JP(1)