UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000778 |
|---|---|
| Receipt number | 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 13:18:38 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
katsua-tky@umin.ac.jp
Sponsor or person
Institute
Department of Nephrology and Endocrinology, University of Tokyo Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
