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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002531
Receipt No. 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

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

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
URL(English) https://upload.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


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