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

Hypertension Clinical Trial

— COMFORT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00670787
• Other study ID #: No. 19041
• Status: Completed
• Phase: Phase 3
• First received: April 30, 2008
• Last updated: March 4, 2011
• Start date: June 2008
• Est. completion date: February 2011

Study information

• Verified date: March 2011
• Source: Kyushu University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: February 2011
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
Japan	Department of Medicine and Clinical Science, Kyushu University	Fukuoka City	Fukuoka

Sponsors (1)

Lead Sponsor	Collaborator
Kyushu University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Medication compliance		6 months	No
Secondary	Blood pressure		6 months	No
Secondary	cost of blood pressure lowering drugs		6 months	No
Secondary	serious adverse events		6 months	Yes
Secondary	adverse events		6 months	Yes
Secondary	blood test		6 months	Yes