UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003741 |
|---|---|
| Receipt number | R000004524 |
| Scientific Title | Efficacy and Safety of Valsartan and Aliskiren Combination Therapy in Patients with Diabetic Nephropathy and Hypertension |
| Date of disclosure of the study information | 2010/06/13 |
| Last modified on | 2013/06/17 14:50:59 |
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Basic information
Public title
Efficacy and Safety of Valsartan and Aliskiren Combination Therapy in Patients with Diabetic Nephropathy and Hypertension
Acronym
Valsartan and Aliskiren Combination Therapy
Scientific Title
Efficacy and Safety of Valsartan and Aliskiren Combination Therapy in Patients with Diabetic Nephropathy and Hypertension
Scientific Title:Acronym
Valsartan and Aliskiren Combination Therapy
Region
| Japan |
Condition
Condition
Type 2 diabetes with nephropathy and hypertension
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To test the efficacy and safety of Valsartan and Aliskiren combination therapy in patients with diabetic nephropathy and hypertension.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
1)estimated GFR
2)Urinary protein excretion(g/gCr)
3)Urinaru Albumin Creatinine Ratio
Key secondary outcomes
1)Change in office and home blood pressure
2)Brain natriuretic peptide
3)Oxidative stress:urinary 8-isoprostane
4)Marker for inflammation: hs-CRP
5)Endthelial function:Flow-mediated vasodilatation(FMD)
6)Arterial stiffness:brachial-ankle pulse wave velocity(baPWV)
7)Arterial thickness:Intima-media thickness of carotid artery(IMT)
8)Renal damage:L-FABP
9)HbA1C, Blood glucose
10)Safety
1.Laboratory data (ALT, AST, BUN, Cr, UA, K)
2.Symptom
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Administration of 80 mg of valsartan
8 weeks after:
administration of 150 mg of aliskiren
4 weeks after administration of aliskiren:
Increase of dose; 300 mg of aliskiren
8 weeks after
Add 1 mg of trichlormethiazide
12 weeks after:
Add 2mg of doxazocin
Interventions/Control_2
Administration of 80 mg of valsartan
8 weeks after:
administration of 5 mg of amlodipine
4 weeks after administration of amlodipine:
Increase of dose;10mg of amlodipine
8 weeks after
Add 1 mg of trichlormethiazide
12 weeks after:
Add 2mg of doxazocin
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
| 30 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Urinary protein<1g/day: systolic BP>=130 mmHg or diastolic BP>=80 mmHg (office BP), or systolic BP>=125 mmHg or diastolic BP>=75 mmHg (home BP) under valsartan treatment
Urinary protein>=1g/day: systolic BP>=125 mmHg or diastolic BP>=75 mmHg (office BP) under valsartan treatment
2) Type 2 diabetes
3) HbA1C<8.0%
4) Urinary albumin/creatinine ratio(UACR)>=100mg/gCr
5) Cr<=3.0 mg/dL
6) Written informed consent is obtained
Key exclusion criteria
1)Taking corticosteroid
2)Secondary hypertension or maliganant hypertension
3)Acute myocardial infarction within 24 weeks
4)Stroke within 12 weeks
5)Severe ventricular tachyarrhythmia or advanced AV block
6)Cardiogenic shock
7)Bilateral renal artery stenosis
8)Sever liver dysfunction
9)Severe hematopoietic disorder or carcinoma
10)Type 1 diabetes
11)Taking cyclosporine A
12)Pregnancy
13)Drug allergy
14) not qualified
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takahashi |
Organization
Kansai Medical University
Division name
The Second Department of Internal Medicine
Zip code
Address
2-3-1 Shinmachi, Hirakata City, Osaka
TEL
072-804-0101
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takahashi |
Organization
Kansai Medical University
Division name
The Second Department of Internal Medicine
Zip code
Address
2-3-1 Shinmachi, Hirakata City, Osaka
TEL
072-804-0101
Homepage URL
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
Novartis Pharma Corp
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
関西医科大学
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 06 | Month | 13 | 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
Terminated
Date of protocol fixation
| 2009 | Year | 12 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 09 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 06 | Month | 12 | Day |
Last modified on
| 2013 | Year | 06 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004524
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