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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000778
Receipt No. R000000929
Scientific Title ONgoing Evaluation of depressor effect And Safety of combination therapy with Telmisartan and low-dose hydrochlorothiazide in patients with hypertension uncontrolled on amlodipin treatment
Date of disclosure of the study information 2007/07/26
Last modified on 2008/08/14

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Basic information
Public title ONgoing Evaluation of depressor effect And Safety of combination therapy with Telmisartan and low-dose hydrochlorothiazide in patients with hypertension uncontrolled on amlodipin treatment
Acronym ONgoing Evaluation of depressor effect And Safety of combination therapy with Telmisartan and low-dose hydrochlorothiazide in patients with hypertension uncontrolled on amlodipin treatment (ONEAST)
Scientific Title ONgoing Evaluation of depressor effect And Safety of combination therapy with Telmisartan and low-dose hydrochlorothiazide in patients with hypertension uncontrolled on amlodipin treatment
Scientific Title:Acronym ONgoing Evaluation of depressor effect And Safety of combination therapy with Telmisartan and low-dose hydrochlorothiazide in patients with hypertension uncontrolled on amlodipin treatment (ONEAST)
Region
Japan

Condition
Condition essential hypertension
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare depressor effect and safety between combination therapy with telmisartan plus low-dose hydrochlorothiazide and amlodipine in hypertensive patients
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes Changes in office blood pressure
Key secondary outcomes 1) Home blood pressure in early morning and before going to bed
2) Changes in uric acid, total cholesterol, HDL cholesterol, LDL cholesterol, triglyceride, fasting plasma glucose (only in diabetic patients), hemoglobin A1c (only in diabetic patients)

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 12 week combination therapy with telmisartan (40 mg/day) plus hydrochlorothiazide (12.5 mg/day): If blood pressure is not reach to lower than 140/90 mmHg, dose of telmisartan can be increased to 80 mg/day.
Interventions/Control_2 Amlodipine (5 mg/day) is continuously administered. If blood pressure is not reach to lower than 140/90 mmHg, amlodipine can b eincreased to 7.5 mg/day.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
40 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1) 5 mg/day of amlodipine is administered for more than 3 months
2) Systolic or diastolic blood pressure >= 140/90 mmHg (more than 2 times measurements at outpatient clinic before start of the study)
3) Outpatients
Key exclusion criteria 1) Secondary hypertension including renovascular hypertension with single kidney or bilateral stenosis
2) Administration of antihypertensives other than amlodipine
3) cardiovascular disease (cerebral hemorrhage, cerebral infarction, TIA, angina, myocardial infarction, acute renal failure) occurs less than 6 months before start of the study
4) Serum creatinine >= 2.0 mg/dl
5) Severe hypertension (systolic or diastolic blood pressure >= 180/110 mmHg) or malignant hypertension (hypertensive organ damage is rapidly developing)
6) Chronic heart failure (NYHA class>=III to VI)
7) Contraindication of telmisartan or hydrochlorothiazide
8) hyper- (>= 5.5 mEq/L) or hypo- (<=3.5 mEq/l) potassemia
9) Untreated hyperuricemia or uncontrolled hydrochlorothiazide (serum uric acid >= 8.0 mg/dl)
10) Diabetic patients who require insulin therapy, uncontrolled diabetic patients (hemoglobin A1c >=9.0%), or patients who possess the risk of hypoglycemic attack
11) Patients inadequate for the study
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Toshiro Fujita
Organization University of Tokyo Graduate School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Katsuyuki Ando
Organization University of Tokyo Graduate School of Medicine
Division name Department of Nephrology and Endocrinology
Zip code
Address 7-3-1 Hongo, Bunkyo-ku, Tokyo
TEL
Homepage URL
Email katsua-tky@umin.ac.jp

Sponsor
Institute Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Institute
Department

Funding Source
Organization Advanced Clinical Research Organization (ACRO)
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2007 Year 07 Month 26 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2007 Year 06 Month 08 Day
Date of IRB
Anticipated trial start date
2007 Year 07 Month 01 Day
Last follow-up date
2008 Year 03 Month 01 Day
Date of closure to data entry
2008 Year 05 Month 01 Day
Date trial data considered complete
2008 Year 08 Month 01 Day
Date analysis concluded
2008 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2007 Year 07 Month 26 Day
Last modified on
2008 Year 08 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000929

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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