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
Recruitment status was Recruiting
Sponsor:
Yokohama City University Medical Center
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
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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:
Drug Information available for:
Hydrochlorothiazide
Amlodipine
Amlodipine besylate
Losartan
Losartan potassium
U.S. FDA Resources
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:
Detailed Description:
-
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)
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
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 Antihypertensive Agents Hydrochlorothiazide Amlodipine Losartan Diuretics Angiotensin Receptor Antagonists Cardiovascular Agents Therapeutic Uses |
Pharmacologic Actions Natriuretic Agents Physiological Effects of Drugs Sodium Chloride Symporter Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Calcium Channel Blockers Vasodilator Agents Anti-Arrhythmia Agents Angiotensin II Type 1 Receptor Blockers |
ClinicalTrials.gov processed this record on May 19, 2013