E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with prediabetes (either impaired glucose tolerance or imparied fasting glucose) and no obvious diabetes mellitus |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10065542 |
E.1.2 | Term | Prediabetes |
E.1.2 | System Organ Class | 10027433 - Metabolism and nutrition disorders |
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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 |
The primary aim of this study is to examine the effect of Aliskiren (150mg/daily for 1 week, 300 mg/daily for 4 weeks) on renal hemodynamics in patients with prediabetes and eleveted blood pressure. |
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E.2.2 | Secondary objectives of the trial |
The effect of a 5 week lasting therapy with Aliskiren on metabolic parameters (HbA1c, high sensitive CRP, Adiponectin), in patients with impaired glucose tolerance and arterial. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Adults aged > 18 to < 70 years
Prediabetes (HbA1c 5.7-6.4 %) impaired fasting glucose (blood glucose 100 - 126 mg/dl) or impaired glucose tolerance (IGT) (Blood glucose > 140 mg/dl and < 200 mg/dl 2 h after an oral glucose administration of 75g) |
Erwachsene im Alter > 18 Jahre und < 70 Jahre
Prädiabetes, definiert als HbA1c 5,7-6,4%, oder gestörter Nüchternglucose, oder gestörter Glukosetoleranz (1 Kriterium reicht), (siehe Diabetes Leitlinien DDG)
Blutdruck > 130/85 mmHg (siehe ESH Guidelines)
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E.4 | Principal exclusion criteria |
Diabetes Mellitus Type 1/2
Micro-, or Macroalbuminuria
Renal insufficiency
Secondary forms of arterial hypertension
Ongoing therapy with ACE-Inhibitors, AT1 blocker, direct renin inhibitor
Antihypertensive therapy with more than 2 agents
Uncontrolled Blood pressure
Known intolerance of direct renin inhibitor
Medical history of cerebral stroke or myocardial infarction within the last 6 months, chronic heart failure NYHA III-IV
Severe gastrointestinal disease
Elevated liver parameters (SGOT, SGPT > more than doubled)
Tablet or alcohol abuse
Adipositas per magna (BMI > 35kg/m²)
Malignant disease
Insufficient Compliance |
Manifester Diabetes Mellitus Typ 1 und 2
Mikro, bzw. Makroalbuminuire
Niereninsuffizienz (Filtration< 60ml)
Sekundäre Form einer arteriellen Hypertonie
Laufende Therapie mit einem ACE-Hemmer, AT 1-Blocker, direkten Reninantagonisten
Blutdrucktherapie mit mehr als zwei Antihypertensiva
Unkontrollierter Bluthochdruck
Bekannte Unverträglichkeit von direkten Reninantagonisten
Apoplex, Myocardinfarkt in den letzten 6 Monaten
Herzinsuffizienz NYHA III-IV
Schwerwiegende Magen-Darmerkrankungen
Leberwerterhöhung (SGOT, SGPT > 2-fach Norm)
Medikamenten- oder Alkoholmissbrauch
Adipositas per magna (BMI > 35kg/m2)
Vorliegen einer malignen Erkrankung
Unzureichende Compliance
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E.5 End points |
E.5.1 | Primary end point(s) |
Renal haemodynamic parameters (glomerular filtration rate, renal plasma flow, filtration fraction) under direct renin blockade |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
E.6.13 | Others | Information not present in EudraCT |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
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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 | No |
E.8.2.3.1 | Comparator description |
with and without treatment |
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E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.5.1 | Number of sites anticipated in the EEA | 1 |
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 | No |
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
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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 | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |