Kanagawa Combination Anti-hypertensive Therapy (K-CAT)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2010 by Yokohama City University Medical Center.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Yokohama City University Medical Center
ClinicalTrials.gov Identifier:
NCT00492128
First received: June 26, 2007
Last updated: June 24, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Losartan/amlodipine or losartan/hydrochlorothiazide
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparative Trial of Combination Therapy of ARB/Diuretic Versus ARB/CCB in Uncontrolled Hypertensive Patients With Monotherapy of ARB

Resource links provided by NLM:


Further study details as provided by Yokohama City University Medical Center:

Primary Outcome Measures:
  • The change of systolic blood pressure [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • The achievement rate of target blood pressure [ Time Frame: three months ] [ Designated as safety issue: Yes ]
  • The change of diastolic blood pressure [ Time Frame: three months ] [ Designated as safety issue: Yes ]
  • The change of blood pressure [ Time Frame: six months, nine months and one year ] [ Designated as safety issue: Yes ]
  • The achievement rate of target blood pressure [ Time Frame: six months, nine months and one year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2007
Estimated Study Completion Date: August 2010
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Losartan/amlodipine or losartan/hydrochlorothiazide
    Losartan 50mg/amlodipine 5mg and the fixed dose combination drug of losartan 50mg/hydrochlorothiazide 12.5mg once a day during 12 months.
    Other Name: Preminent (Hyzaar)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00492128

Contacts
Contact: Satoshi Umemura, MD, PhD 81-45-787-2635 umemuras@med.yokohama-cu.ac.jp

Locations
Japan
Yokohama City University Graduate School of Medicine Recruiting
Yokohama, Kanagawa, Japan, 236-0004
Sponsors and Collaborators
Yokohama City University Medical Center
Investigators
Study Chair: Satoshi Umemura, MD, PhD Yokohama City University Graduate School of Medicine
  More Information

No publications provided

Responsible Party: Yokohama City University Medical Center, Department of Medical Science and Cardiorenal
ClinicalTrials.gov Identifier: NCT00492128     History of Changes
Other Study ID Numbers: 200706001
Study First Received: June 26, 2007
Last Updated: June 24, 2010
Health Authority: Japan: Institutional Review Board

Keywords provided by Yokohama City University Medical Center:
hypertension
angiotensin receptor blocker
diuretic
combination therapy

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Losartan
Amlodipine
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Arrhythmia Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Calcium Channel Blockers
Vasodilator Agents

ClinicalTrials.gov processed this record on October 19, 2014