Efficacy and Safety of Valsartan and Aliskiren Combination Therapy in Patients with Diabetic Nephropathy and Hypertension

Efficacy and Safety of Valsartan and Aliskiren Combination Therapy in Patients with Diabetic Nephropathy and Hypertension - Valsartan and Aliskiren Combination Therapy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000003741

Enrollment

Registered

2010-06-13

Start date

2010-06-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 diabetes with nephropathy and hypertension

Interventions

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 Administration of 80 mg of valsartan 8 weeks after: administration of 5 mg of amlodipine

10mg of amlodipine 8 weeks after Add 1 mg of trichlormethiazide 12 weeks after: Add 2mg of doxazocin

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
1)estimated GFR 2)Urinary protein excretion(g/gCr) 3)Urinaru Albumin Creatinine Ratio	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactNobuyuki Takahashi

Kansai Medical University The Second Department of Internal Medicine

072-804-0101

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026