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

March 4, 2011 updated by: Kyushu University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Fukuoka
      • Fukuoka City, Fukuoka, Japan, 812-8582
        • Department of Medicine and Clinical Science, Kyushu University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Combination pill
Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning
Drug: Combination pill of losartan and hydrochlorothiazide
Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning
Other Names:
  • Preminent
No Intervention: 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Medication compliance
Time Frame: 6 months
6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
adverse events
Time Frame: 6 months
6 months
Blood pressure
Time Frame: 6 months
6 months
cost of blood pressure lowering drugs
Time Frame: 6 months
6 months
serious adverse events
Time Frame: 6 months
6 months
blood test
Time Frame: 6 months
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kyushu University

Investigators

  • Principal Investigator: Kiyoshi Matsumura, MD PhD, Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

February 1, 2011

Study Registration Dates

First Submitted

April 30, 2008

First Submitted That Met QC Criteria

May 1, 2008

First Posted (Estimate)

May 2, 2008

Study Record Updates

Last Update Posted (Estimate)

March 7, 2011

Last Update Submitted That Met QC Criteria

March 4, 2011

Last Verified

March 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No. 19041

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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