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Completed

NCT Number: NCT00670787

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

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.

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Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Department of Medicine and Clinical Science, Kyushu University

Fukuoka, 812-8582, Japan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Combination pill of losartan and hydrochlorothiazide

Drug

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

Other names: Preminent

Primary outcomes

  1. Medication compliance

    Time frame: 6 months

Secondary outcomes

  1. Blood pressure

    Time frame: 6 months

  2. cost of blood pressure lowering drugs

    Time frame: 6 months

  3. serious adverse events

    Time frame: 6 months

  4. adverse events

    Time frame: 6 months

  5. blood test

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Kyushu University

Other

Registry information

Official study 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.

Acronym: COMFORT

Important dates

Study start
2008
Primary completion
2010
Study completion
2011
First posted
May 2, 2008
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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