Unique ID issued by UMIN | UMIN000004059 |
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Receipt number | 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 09:10:48 |
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
A pilot study of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes
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
A pilot study of combination therapy with angiotensin receptor blocker and renin inhibitor for patients with chronic heart failure combined with hypertension and diabetes
Japan |
Chronic heart failure combined with hypertension and diabetes
Cardiology |
Others
NO
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.
Safety,Efficacy
Serum brain natriuretic peptide level (After 12 and 24 weeks)
Interventional
Parallel
Randomized
Open -no one is blinded
Active
2
Treatment
Medicine |
Add Aliskiren 150mg/day (up to 300mg/day) to Valsartan 80mg/day for 24 weeks
Add Amlodipine 2.5mg/day (up to 5mg/day) to Valsartan 80mg/day for 24 weeks
20 | years-old | <= |
80 | years-old | > |
Male and Female
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
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
60
1st name | |
Middle name | |
Last name | Masaaki Hoshiga |
Osaka Medical College
First Department of Internal Medicine
Daigakumachi 2-7, Takatsuki, Osaka 5698686, JAPAN
1st name | |
Middle name | |
Last name |
Osaka Medical College
First Department of Internal Medicine
Daigakumachi 2-7, Takatsuki, Osaka 5698686, JAPAN
Osaka Medical College
Osaka Medical College
Self funding
NO
2010 | Year | 09 | Month | 01 | Day |
Unpublished
Enrolling by invitation
2010 | Year | 08 | Month | 18 | Day |
2010 | Year | 09 | Month | 01 | Day |
2010 | Year | 08 | Month | 18 | Day |
2012 | Year | 08 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004894
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