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.”

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

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

Study Primary Completion Date: March 2010

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.

Intervention(s) in this Clinical Trial

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

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: Combination pill
  • Combination pill of losartan potassium 50mg and hydrochlorothiazide 12.5mg in the morning
• 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)

Primary Measures

• Medication compliance
  • Time Frame: 6 months
    Safety Issue?: No

Secondary Measures

• Blood pressure, cost of blood pressure lowering drugs, serious adverse events, adverse events, blood test
  • Time Frame: 6 months
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 20 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Kyushu University

Overall Clinical Trial Officials and Contacts

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

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

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00670787

Study ID Number: No. 19041

ClinicalTrials.gov Identifier: NCT00670787

Health Authority: Japan: Ministry of Health, Labor and Welfare