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

A Randomized Trial to Establish the Effects of Combination Pill of Losartan Potassium and Hydrochlorothiazide on Medication Compliance Among Patients With High Blood Pressure.

Status
Completed
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00670787
Acronym
COMFORT
Enrollment
207
Registered
2008-05-02
Start date
2008-06-30
Completion date
2011-02-28
Last updated
2011-03-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Keywords

Hypertension, combination pill, compliance

Brief summary

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

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.

Interventions

DRUGCombination pill of losartan and hydrochlorothiazide

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

Sponsors

Kyushu University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Medication compliance6 months

Secondary

MeasureTime frame
Blood pressure6 months
cost of blood pressure lowering drugs6 months
serious adverse events6 months
adverse events6 months
blood test6 months

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026