UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004288 |
|---|---|
| Receipt number | R000002445 |
| Scientific Title | Combination Therapy of Olmesartan and Azelnidipine or Valsartan and Amlodipine in Hypertensinve Patients Study |
| Date of disclosure of the study information | 2010/09/28 |
| Last modified on | 2011/09/27 11:44:10 |
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Basic information
Public title
Combination Therapy of Olmesartan and Azelnidipine or Valsartan and Amlodipine in Hypertensinve Patients Study
Acronym
COAST
Scientific Title
Combination Therapy of Olmesartan and Azelnidipine or Valsartan and Amlodipine in Hypertensinve Patients Study
Scientific Title:Acronym
COAST
Region
| Japan |
Condition
Condition
Hypertension
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effects of ARB (olmesartan and valsartan)-based combination therapy on the severity of cardiac failure, cardiac function disturbance, and blood surrogate markers in hypertensive subjects with cardiac function disturbance.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Changes in the value of various biomarkers from baseline.
BNP,
hs-CRP,
ADMA
Key secondary outcomes
Changes in the value of various biomarkers from baseline.
The proportion of patients who achieved the blood pressure goal (<130/80mmHg) after 6 months drug administration.
The time course evaluation of blood pressure lowering effect.
Blood tests (blood glucose, lipid, liver function, renal function).
Echo-cardiography tests (EF, E/A, DT, LVDd, LVDs, LAD, LVMass).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
olmesartan plus azelnidipine group
Interventions/Control_2
valsartan plus amlodipine group
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
To determine the effects of ARB (olmesartan and valsartan)-based combination therapy on the severity of cardiac failure, cardiac function disturbance, and blood surrogate markers in hypertensive subjects with cardiac function disturbance.
Inclusion criteria:
(1) Hypertensive (>=140/90 mmHg) subjects with untreated or treated cardiac function disturbance. In principle, subjects with hypertension who have been on antihypertensive monotherapy with the most recent casual seated SBP of >=140 mmHg or seated DBP of >=90 mmHg twice.
(2) Subjects with a BNP of >=40 pg/mL.
(3) Male or female subjects aged 20 years or older as of the start of observation.
(4) Inpatients or outpatients.
(5) Subjects allowed to switch their current antihypertensive drug to an investigational drug of the study based on the judgment of the investigator.
Key exclusion criteria
(1) Subjects with cardiogenic shock or a SBP of <80 mmHg.
(2) Subjects with serious arrhythmia (such as persistent ventricular tachycardia and ventricular fibrillation), bradycardia (<50 beat/min), or second-degree or greater atrioventricular block.
(3) Subjects who have developed acute cardiac infarction within 3 months prior to informed consent.
(4) Subjects with unstable angina, coronary spastic angina, or angina at rest.
(5) Subjects who have undergone CABG or PCI within 3 months prior to informed consent or are going to undergo CABG or PCI during the study.
(6) Subjects who have developed cerebrovascular disorders (such as cerebral hemorrhage and subarachnoid hemorrhage) within 6 months prior to informed consent.
(7) Subjects with bronchial asthma or other chronic respiratory disease and cor pulmonale.
(8) Subjects with a history of disease with a serious prognosis such as advanced cancer within 5 years prior to informed consent.
(9) Subjects with arteriosclerosis obliterans (stage II or greater in Leriche Fontaine's classification).
(10) Subjects with poorly controlled diabetes mellitus (subjects with an HbAlc of >=8.0% even in antidiabetic treatment).
(11) Subjects with the following serious complications: renal disorder (e.g., persistent creatinine of >=3.0 mg/dL), hepatic disorder (e.g., persistent AST or ALT of >=100 units), and anemia (e.g., persistent Hb of <=8.0 mg/dL).
(12) Subjects with thyroid dysfunction difficult to control with treatment.
(13) Pregnant and lactating women, women of childbearing potential, or women who want to get pregnant during the study.
(14) Subjects with a history of hypersensitivity to olmesartan, valsartan, azelnidipine, and/or amlodipine.
(15) Subjects for whom the administration of olmesartan, valsartan, azelnidipine, and/or amlodipine is contraindicated.
(16) Subjects who are unable to give informed consent in writing.
(17) Subjects judged by the investigator to be ineligible for the study due to other reasons.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuki Kihara |
Organization
Hiroshima University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
082-257-5540
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Hiroshima University
Division name
Department of Cardiovascular Medicine
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima
TEL
Homepage URL
Sponsor or person
Institute
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
広島大学病院 他23施設
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 09 | Month | 28 | 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
| 2008 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 09 | Month | 28 | Day |
Last modified on
| 2011 | Year | 09 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002445
