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

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 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


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

Value
https://center6.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