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Completed

NCT Number: NCT00492128

Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

The purpose of this study is to compare the effect and safety of the antihypertensive combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

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Key information

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Yokohama City University Graduate School of Medicine

Yokohama, Kanagawa, 236-0004, Japan

About this study

The combination therapy with multiple antihypertensive drugs is recommended in the patients who are uncontrolled with monotherapy. Diuretics increase the activities of renin-angiotensin-aldosterone system (RAS), and angiotensin receptor blockers (ARB) depress blood pressure potently in the state of increased RAS activities. Thus, the combination therapy with ARB and diuretics is expected to lower the blood pressure synergistically. This combination therapy is also expected to reduce the side effects of each drug. In this study, we will compare the effect and safety of the combination therapies between losartan/amlodipine and fixed dose drug of losartan/hydrochlorothiazide.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Under treatment of hypertension with ARB monotherapy for more than one month.
  • systolic blood pressure more than 140mmHg and less than 160mmHg or diastolic blood pressure more than 90mmHg and less than 100mmHg in sitting position.
  • In diabetic or CKD patients, systolic blood pressure more than 130mmHg and less than 160mmHg or diastolic blood pressure more than 80mmHg and less than 100mmHg in sitting position.

Exclusion criteria

  • uncontrolled hypertension (diastolic blood pressure >120mmHg)
  • uncontrolled diabetes mellitus (HbA1c>9.0%)
  • Acute myocardial infarction, stroke and other cardiovascular events within six months
  • The history of gout, or uric acid>8.0mg/dl
  • Serum creatinine>2.0mg/dl
  • sever liver dysfunction
  • Bilateral renovascular stenosis
  • secondary hypertension
  • malignant hypertension
  • uncontrolled arrhythmia
  • pregnancy or possibility of pregnancy
  • hypersensitivity to trial drug

Treatment and study plan

Losartan/amlodipine or losartan/hydrochlorothiazide

Drug

Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.

Other names: Preminent (Hyzaar)

Primary outcomes

  1. The change of systolic blood pressure

    Time frame: three months

Secondary outcomes

  1. The achievement rate of target blood pressure

    Time frame: three months

  2. The change of diastolic blood pressure

    Time frame: three months

  3. The change of blood pressure

    Time frame: six months, nine months and one year

  4. The achievement rate of target blood pressure

    Time frame: six months, nine months and one year

Sponsors and collaborators

Lead sponsor

Yokohama City University Medical Center

Other

Registry information

Official study title

Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Jun 27, 2007
Registry last updated
Jan 30, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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