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

Kyushu University

Status and phase: Completed; Phase 3

Conditions: Hypertension

Treatments: Drug: Combination pill of losartan and hydrochlorothiazide

Study type: Interventional

Funder types: Other

Identifiers

NCT00670787

No. 19041

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

Combination pill

Active Comparator group

Description:

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

Treatment:

Drug: Combination pill of losartan and hydrochlorothiazide

Control group

No Intervention group

Description:

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)