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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000003741
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Kansai Medical University
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004524

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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