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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00670787
Recruitment Status : Completed
First Posted : May 2, 2008
Last Update Posted : March 7, 2011
Sponsor:
Information provided by:
Kyushu University

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Hypertension Drug: Combination pill of losartan and hydrochlorothiazide Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 207 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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.
Study Start Date : June 2008
Actual Primary Completion Date : November 2010
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Medicines Potassium

Arms and Interventions
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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 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)


Outcome Measures
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Primary Outcome Measures :
  1. Medication compliance [ Time Frame: 6 months ]

Secondary Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00670787


Locations
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Japan
Department of Medicine and Clinical Science, Kyushu University
Fukuoka City, Fukuoka, Japan, 812-8582
Sponsors and Collaborators
Kyushu University
Investigators
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Principal Investigator: Kiyoshi Matsumura, MD PhD Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
More Information
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Responsible Party: Kiyoshi Matsumura, Department of Medicine and Clinical Science, Kyushu University
ClinicalTrials.gov Identifier: NCT00670787    
Other Study ID Numbers: No. 19041
First Posted: May 2, 2008    Key Record Dates
Last Update Posted: March 7, 2011
Last Verified: March 2011
Keywords provided by Kyushu University:
Hypertension
combination pill
compliance
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases
Losartan
Hydrochlorothiazide
Anti-Arrhythmia Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
 Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators