A Phase II a, Double-Blind, Randomized, Parallel-Design, Four-week Study to Investigate the Efficacy and Safety of Two Different Doses of the Renin-inhibitor SPP635 Once Daily in Type II Diabetic Patients With Mild to Moderate Hypertension and Albuminuria

Conditions: Diabetes mellitus type II with mild to moderate hypertension and albuminuria
MedDRA version: 9.1Level: LLTClassification code 10045250Term: Type II diabetes mellitus with renal manifestations
MedDRA version: 9.1Level: LLTClassification code 10001580Term: Albuminuria
MedDRA version: 9.1Level: LLTClassification code 10045248Term: Type II diabetes mellitus with other specified manifestations
MedDRA version: 9.1Level: LLTClassification code 10020772Term: Hypertension

Registration Number: EUCTR2007-004559-12-HU

Lead Sponsor: Speedel Pharma Ltd.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

Men and women aged between 18 and 75 years;
Diagnosed with Type II diabetes with HbA1c of = 6.5 %;
Mean sitting systolic office BP (SBP) = 150 mm Hg at screening;
At baseline, after wash-out a mean sitting SBP = 8 mm Hg higher than at screening but = 179 mm Hg;
Albuminuria as indicated by mean urinary ACR of = 2.5 mg/mmol (males) or = 3.5 mg/mmol (females) at screening or by 24h albuminuria of = 30 mg at baseline
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Pregnant or lactating women or any women of child-bearing potential who do not use double contraception with at least one method being a barrier contraceptive;
Heart failure, stroke, myocardial infarction, transient ischaemic attack, or hypertensive encephalopathy within the past 6 months;
Current or past history of clinically significant electrocardiogram (ECG) abnormalities such as permanent 2nd degree atrioventricular (AV) block or higher, unstable angina, percutaneous transluminal coronary angioplasty (PTCA), coronary artery bypass graft (CABG) or cerebrovascular accident in the last three months;
Any history or presence of kidney damage as indicated by a mean urinary ACR of = 34 mg/mmol at screening;
Treatment with Aliskiren;

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the effect of 200 and 450 mg SPP635 once daily on (systolic and diastolic) ambulatory blood pressure (ABPM) compared to baseline, split into daytime blood pressure (BP), night time BP and 24 h BP;Secondary Objective: •To assess the effect of 200 and 450 mg SPP635 once daily on albuminuria versus baseline investigated as 24 h urinary albumin excretion and urinary albumin:creatinine ratio (ACR).<br>•To assess the effect of 200 and 450 mg SPP635 once daily on trough sitting office BP (systolic and diastolic) compared to baseline.<br>•To assess the effect of 200 and 450 mg SPP635 once daily on Plasma Renin Activity (PRA).<br>•To assess plasma levels of SPP635.<br>•To assess the safety and tolerability of 200 and 450 mg SPP635 once daily<br>;Primary end point(s): Change of BP measured by ABPM (systolic and diastolic) at baseline and after 4 weeks of treatment or after early discontinuation; split into daytime, nighttime and 24h BP

Secondary Outcome Measures

Name	Time	Method

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