Combination Pill of Losartan Potassium and Hydrochlorothiazide for Improvement of Medication Compliance Trial - Full Text View

Sponsor:	Kyushu University
Information provided by:	Kyushu University
ClinicalTrials.gov Identifier:	NCT00670787

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 III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
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:

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Losartan Losartan potassium Potassium chloride

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, cost of blood pressure lowering drugs, serious adverse events, adverse events, blood test [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	400
Study Start Date:	June 2008
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Combination pill: Active Comparator 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
Control group: No Intervention 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

Contacts

Contact: Hisatomi Arima, MD PhD	81-92-642-5256	harima@intmed2.med.kyushu-u.ac.jp
Contact: Kiyoshi Matsumura, MD PhD	81-92-642-5256	matsumk@intmed2.med.kyushu-u.ac.jp

Locations

Japan, Fukuoka
Department of Medicine and Clinical Science, Kyushu University	Recruiting
Fukuoka City, Fukuoka, Japan, 812-8582
Contact: Hisatomi Arima, MD PhD 81-92-642-5256 harima@intmed2.med.kyushu-u.ac.jp
Contact: Kiyoshi Matsumura, MD PhD 81-92-642-5256 matsumk@intmed2.med.kyushu-u.ac.jp
Principal Investigator: Kiyoshi Matsumura, MD PhD
Sub-Investigator: Toshiyuki Sasaguri, MD PhD
Sub-Investigator: Toshio Ohtsubo, MD PhD
Sub-Investigator: Hisatomi Arima, MD PhD

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:	Department of Medicine and Clinical Science, Kyushu University ( Kiyoshi Matsumura )
Study ID Numbers:	No. 19041
Study First Received:	April 30, 2008
Last Updated:	February 1, 2010
ClinicalTrials.gov Identifier:	NCT00670787 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Kyushu University:

Hypertension
combination pill
compliance

Additional relevant MeSH terms:

Losartan
Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Cardiovascular Agents
Antihypertensive Agents
Hydrochlorothiazide

Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Anti-Arrhythmia Agents
Hypertension

ClinicalTrials.gov processed this record on February 08, 2010