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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000004059
Receipt No. R000004894
Scientific Title A pilot study regarding efficacy and safety of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes
Date of disclosure of the study information 2010/09/01
Last modified on 2012/08/18

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Basic information
Public title A pilot study regarding efficacy and safety of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes
Acronym A pilot study of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes
Scientific Title A pilot study regarding efficacy and safety of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes
Scientific Title:Acronym A pilot study of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes
Region
Japan

Condition
Condition Chronic heart failure combined with hypertension and diabetes
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effectiveness of combination therapy with angiotensin receptor blocker and renin inhibitor for cardiac involvement combined with diabetes in the clinical setting, which has been suggested in animal studies.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Serum brain natriuretic peptide level (After 12 and 24 weeks)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Add Aliskiren 150mg/day (up to 300mg/day) to Valsartan 80mg/day for 24 weeks
Interventions/Control_2 Add Amlodipine 2.5mg/day (up to 5mg/day) to Valsartan 80mg/day for 24 weeks
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
80 years-old >
Gender Male and Female
Key inclusion criteria 1. chronic heart failure combined with hypertension and type 2 diabetes
2.serum BNP equal to or more than 100mg/dl
3. SBP equal to or more than 130 or DBP equal to or more than 80mmHg in hospital (or SBP equal to or more than 125 or DBP equal to or more than 75mmHg on home blood pressure monitoring) after 4 weeks of Valsartan 80mg/day administration during observation period
4. Serum creatinine less than 3.0mg/dl
Key exclusion criteria 1. Within 24 weeks after initiation of statin, fibrates, or diabetes drug other than insulin
2. Within 24 weeks after onset of acute myocardial infarction
3. Within 12 weeks after onset of stroke
4. Severe ventricular arrhythmia or AV block (second or third degree)
5. Cardiogenic shock
6. Secondary hypertension other than renal hypertension
7. Bilateral renal artery stenosis
8. Hypertensive emergency including malignant hypertension
9. Severe liver damage
10. Severe hemopoietic disorder or malignancy
11. Type 1 diabetes
12. During Cyclosporine administration
13. During pregnancy or lactation. Woman of child-bearing potential
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaaki Hoshiga
Organization Osaka Medical College
Division name First Department of Internal Medicine
Zip code
Address Daigakumachi 2-7, Takatsuki, Osaka 5698686, JAPAN
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka Medical College
Division name First Department of Internal Medicine
Zip code
Address Daigakumachi 2-7, Takatsuki, Osaka 5698686, JAPAN
TEL
Homepage URL
Email

Sponsor
Institute Osaka Medical College
Institute
Department

Funding Source
Organization Osaka Medical College
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

Other administrative information
Date of disclosure of the study information
2010 Year 09 Month 01 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 Enrolling by invitation
Date of protocol fixation
2010 Year 08 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 08 Month 18 Day
Last modified on
2012 Year 08 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004894

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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