Combination Pill of Losartan Potassium and Hydrochlorothiazide for Improvement of Medication Compliance Trial

NCT ID: NCT00670787

Last Updated: 2011-03-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2011-02-28

Brief Summary

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The purpose of the study is to determine whether combination pill of losartan potassium and hydrochlorothiazide will improve medication compliance among patients with high blood pressure.

Detailed Description

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Despite clear evidence that blood pressure lowering treatment is beneficial for reduction of cardiovascular disease, blood pressure levels are not adequately controlled in many hypertensive patients. More intensive blood pressure lowering treatment is required to achieve maximum reduction of cardiovascular disease. Combination pills of blood pressure lowering drugs could be a safe and effective strategy to achieve blood pressure target but there is no randomized evidence that established the beneficial effects of combination pills of blood pressure lowering drugs. The purpose of the study is to determine whether combination pill of losartan potassium and hydrochlorothiazide will improve medication compliance among patients with high blood pressure.

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Combination pill

Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning

Group Type ACTIVE_COMPARATOR

Combination pill of losartan and hydrochlorothiazide

Intervention Type DRUG

Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning

Control group

combination therapy of angiotensin receptor antagonists (losartan potassium 50mg, candesartan 8mg, valsartan 80mg, telmisartan 40mg or olmesartan 20mg) and thiazide or thiazide-like diuretics (hydrochlorothiazide 6.25-12.5mg, trichlormethiazide 0.5-1.0mg, indapamide 0.5-1.0mg or chlorthalidone 6.25-12.5mg)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Combination pill of losartan and hydrochlorothiazide

Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning

Intervention Type DRUG

Other Intervention Names

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Preminent

Eligibility Criteria

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Inclusion Criteria

* Aged 20 years or above
* Hypertension defined as blood pressure levels of \>/=140/90mmHg or current use of blood pressure lowering drugs
* Able to commence combination therapy of angiotensin receptor antagonists and diuretics

Exclusion Criteria

* Blood pressure measurements of \>/=200/120mmHg
* Previous serious adverse events due to angiotensin receptor antagonists or diuretics
* Known or possible pregnancy
* Known severe liver dysfunction
* Known severe kidney disease
* Known contraindication to angiotensin receptor antagonists or diuretics
* Taking \>/=4 tablets except for angiotensin receptor antagonists
* ACE inhibitors, thiazide or thiazide-like diuretics in the morning
* Current participation in another clinical trial
* A high likelihood that the patient is not suitable for the study treatment
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyushu University

OTHER

Sponsor Role lead

Responsible Party

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Department of Medicine and Clinical Science, Kyushu University

Principal Investigators

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Kiyoshi Matsumura, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University

Locations

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Department of Medicine and Clinical Science, Kyushu University

Fukuoka, Fukuoka, Japan

Site Status

Countries

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Japan

Other Identifiers

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No. 19041

Identifier Type: -

Identifier Source: org_study_id

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