Diabetes mellitus type II with mild to moderate hypertension and albuminuria MedDRA version: 9.1 Level: LLT Classification code 10045250 Term: Type II diabetes mellitus with renal manifestations MedDRA version: 9.1 Level: LLT Classification code 10001580 Term: Albuminuria MedDRA version: 9.1 Level: LLT Classification code 10045248 Term: Type II diabetes mellitus with other specified manifestations MedDRA version: 9.1 Level: LLT Classification code 10020772 Term: Hypertension
Conditions
Interventions
Product Code: SPP635
Pharmaceutical Form: Capsule, hard
Current Sponsor code: SPP635
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 150-
Product Code: SPP635
Phar
Sponsors
Speedel Pharma Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
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
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;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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;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 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). • To assess the effect of 200 and 450 mg SPP635 once daily on trough sitting office BP (systolic and diastolic) compared to baseline. • To assess the effect of 200 and 450 mg SPP635 once daily on Plasma Renin Activity (PRA). • To assess plasma levels of SPP635. • To assess the safety and tolerability of 200 and 450 mg SPP635 once daily | — |
Countries
Hungary, Ireland
Outcome results
None listed