E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes mellitus type II with mild to moderate hypertension and albuminuria |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045250 |
E.1.2 | Term | Type II diabetes mellitus with renal manifestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10001580 |
E.1.2 | Term | Albuminuria |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045248 |
E.1.2 | Term | Type II diabetes mellitus with other specified manifestations |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10020772 |
E.1.2 | Term | Hypertension |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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 |
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E.2.2 | Secondary objectives of the trial |
• 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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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; |
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E.4 | Principal 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; |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 12 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
The trial ends with the last patient's last visit |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | |
E.8.9.1 | In the Member State concerned months | 7 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial months | 7 |