Clinical trial NCT00670787: Combination Pill of Losartan Potassium and Hydrochlorothiazide for Improvement of Medication Compliance Trial
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Hypertension
combination pill
compliance
Lead sponsor: Kyushu University
Sponsor class: OTHER
First posted: 2008-05-02
Enrollment: 207
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Medication compliance
timeFrame: 6 months
Secondary outcomes:
measure: Blood pressure
timeFrame: 6 months
measure: cost of blood pressure lowering drugs
timeFrame: 6 months
measure: serious adverse events
timeFrame: 6 months
measure: adverse events
timeFrame: 6 months
measure: blood test
timeFrame: 6 months
Other outcomes:
Locations:
city: Fukuoka City
country: Japan
facility: Department of Medicine and Clinical Science, Kyushu University
state: Fukuoka
Study officials:
affiliation: Department of Medicine and Clinical Science, Graduate School of Medical Sciences, Kyushu University
name: Kiyoshi Matsumura, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: