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-IE
• Lead Sponsor: Speedel Pharma Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-09-10
• Last Update Posted: 19 March 2012

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 urinary ACR of = 2.5 mg/mmol (males) or = 3.5 mg/mmol (females) at screening;
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 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