UMIN-CTR Clinical Trial

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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