UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000002531
Receipt number R000003091
Scientific Title Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering
Date of disclosure of the study information 2009/09/18
Last modified on 2015/09/19 09:45:00

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Basic information

Public title

Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering

Acronym

Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering

Scientific Title

Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering

Scientific Title:Acronym

Combination Therapy of Angiotensin II Receptor Blocker and Calcium Channel Blocker Exerts Pleiotropic Therapeutic Effects in Addition to Blood Pressure Lowering

Region

Japan


Condition

Condition

Hypertension

Classification by specialty

Medicine in general Cardiology Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

This study aimed to examine beneficial effects of combination therapy with candesartan and amlodipine on BP control and markers of target organ function in Japanese essential hypertensive patients who did not achieve the target BP level during the monotherapy period either by candesartan or amlodipine.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

A. Clinic blood pressure
B. Home blood pressure profile
C. Renal function including eGFR and urinary protein/albumin excretion.
D. Vascular function including central BP, AI, baPWV and ABI.

Key secondary outcomes

1. Glucose metabolism including FPG, IRI, HOMA-IR, HbA1C.
2. Lipid metabolism including T-cho, LDL-cho, HDL-cho, and TG.
3. Activity of sympathetic nerve and renin-angiotensinsystem including PRA, PAC, catecholamine, and urinary angiotensinogen.
4. Oxidative stress marlers including pentosidine and urinary L-FABP.
5. Cardiac function including BNP, cardiac echographic parameters.
6. CBC, electrolyte, and liver function.
7. Adverse events.


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

This study consisted of a 4-week mono therapy period and 12-week combination therapy period. The patients already being treated with amlodipine, a once-daily 8 mg dose of candesartan was added-on during the combination therapy period, and a once-daily 5 mg dose of amlodipine was added-on for those already being treated with candesartan.

Interventions/Control_2


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

The eligible subjects were mild-to-moderate essential hypertensive patients who were already treated with a once-daily 5 mg dose of amlodipine monotherapy or with a once-daily 8 mg dose of candesartan monotherapy at the initiation of the monotherapy period and did not achieve the target BP level according to the Japanese Society of Hypertension Guidelines for the Management of Hypertension (JSH2009) during the monotherapy period .

Key exclusion criteria

Exclusion criteria included patients who exhibited severe hypertension (clinic systolic >= 180 mmHg and/or diastolic BP >= 110 mmHg), renal insufficiency (estimated glomerular filtration < 30 ml/min/1.73 m2), women who were nursing or pregnant, clinically significant heart disease, moderate-to-severe hepatic dysfunction, and known hypersensitivity to any component of the study medications.

Target sample size

30


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Kouichi TAMURA

Organization

Yokohama City University School of Medicine

Division name

Dapartment of Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2635

Email

tamukou@med.yokohama-cu.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kouichi TAMURA

Organization

Yokohama City University School of Medicine

Division name

Dapartment of Cardiorenal Medicine

Zip code


Address

3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN

TEL

045-787-2635

Homepage URL


Email

tamukou@med.yokohama-cu.ac.jp


Sponsor or person

Institute

Department of Medical Science and Cardiorenal Medicine, Yokohama City University Graduate School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Self

Organization

Division

Category of Funding Organization

Self funding

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

横浜市立大学附属病院
Yokohama City University Hospital


Other administrative information

Date of disclosure of the study information

2009 Year 09 Month 18 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

2009 Year 12 Month 10 Day

Date of IRB


Anticipated trial start date

2009 Year 12 Month 10 Day

Last follow-up date

2013 Year 12 Month 09 Day

Date of closure to data entry

2014 Year 12 Month 09 Day

Date trial data considered complete

2015 Year 12 Month 09 Day

Date analysis concluded

2016 Year 12 Month 09 Day


Other

Other related information



Management information

Registered date

2009 Year 09 Month 18 Day

Last modified on

2015 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003091


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name