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

This study has been completed.
Sponsor:
Information provided by:
Kyushu University
ClinicalTrials.gov Identifier:
NCT00670787
First received: April 30, 2008
Last updated: March 4, 2011
Last verified: March 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Drug: Combination pill of losartan and hydrochlorothiazide
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Kyushu University:

Primary Outcome Measures:
  • Medication compliance [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood pressure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • cost of blood pressure lowering drugs [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • serious adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • adverse events [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • blood test [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Enrollment: 207
Study Start Date: June 2008
Study Completion Date: February 2011
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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)

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.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00670787

Locations
Japan
Department of Medicine and Clinical Science, Kyushu University
Fukuoka City, Fukuoka, Japan, 812-8582
Sponsors and Collaborators
Kyushu University
Investigators
Principal Investigator: Kiyoshi Matsumura, MD PhD Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
  More Information

No publications provided

Responsible Party: Kiyoshi Matsumura, Department of Medicine and Clinical Science, Kyushu University
ClinicalTrials.gov Identifier: NCT00670787     History of Changes
Other Study ID Numbers: No. 19041
Study First Received: April 30, 2008
Last Updated: March 4, 2011
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyushu University:
Hypertension
combination pill
compliance

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Contraceptives, Oral
Hydrochlorothiazide
Losartan
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Therapeutic Uses
Diuretics
Natriuretic Agents
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 18, 2013