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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004288
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Hiroshima University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002445

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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