Página Nct de ensaios clínicos

Summary
EudraCT Number:2008-008287-28
Sponsor's Protocol Code Number:ALI-FRA-0030-I
National Competent Authority:Germany - BfArM
Clinical Trial Type:EEA CTA
Trial Status:Completed
Date on which this record was first entered in the EudraCT database:2010-04-13
Trial results
Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL
A. Protocol Information
A.1Member State ConcernedGermany - BfArM
A.2EudraCT number2008-008287-28
A.3Full title of the trial
Effect of direct renin-inhibition aliskiren on renal haemodynamic and metabolic parameters in patients with prediabetes
Effekt des direkten Renin-Inhbitor Aliskiren auf die renale Hämodynamik und auf metabolische Parameter bei Patienten mit Prädiabetes
A.3.2Name or abbreviated title of the trial where available
AMARYLIS
AMARYLIS
A.4.1Sponsor's protocol code numberALI-FRA-0030-I
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorUniversity Hospital Erlangen
B.1.3.4CountryGermany
B.3.1 and B.3.2Status of the sponsorNon-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportNovartis
B.4.2CountryGermany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Rasilez 150 mg
D.2.1.1.2Name of the Marketing Authorisation holderNovartis
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRasilez
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Rasilez 300 mg
D.2.1.1.2Name of the Marketing Authorisation holderNovartis
D.2.1.2Country which granted the Marketing AuthorisationGermany
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRasilez
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPOral use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product No
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Patients with prediabetes (either impaired glucose tolerance or imparied fasting glucose) and no obvious diabetes mellitus
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 14.1
E.1.2Level LLT
E.1.2Classification code 10065542
E.1.2Term Prediabetes
E.1.2System Organ Class 10027433 - Metabolism and nutrition disorders
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main 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.
E.2.2Secondary 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.
E.2.3Trial contains a sub-study No
E.3Principal 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)
E.4Principal 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
E.5 End points
E.5.1Primary end point(s)
Renal haemodynamic parameters (glomerular filtration rate, renal plasma flow, filtration fraction) under direct renin blockade
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Information not present in EudraCT
E.6.2Prophylaxis Information not present in EudraCT
E.6.3Therapy Yes
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Information not present in EudraCT
E.6.7Pharmacodynamic Information not present in EudraCT
E.6.8Bioequivalence Information not present in EudraCT
E.6.9Dose response Information not present in EudraCT
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic Information not present in EudraCT
E.6.12Pharmacoeconomic Information not present in EudraCT
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised No
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group No
E.8.1.6Cross over No
E.8.1.7Other Yes
E.8.1.7.1Other trial design description
case control study
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) No
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.3.1Comparator description
with and without treatment
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.8.4.1Number of sites anticipated in Member State concerned1
E.8.5The trial involves multiple Member States No
E.8.5.1Number of sites anticipated in the EEA1
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.7Trial 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
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months
E.8.9.1In the Member State concerned days
E.8.9.2In all countries concerned by the trial years1
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception No
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state20
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 20
F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
All study participants will be examined at the end of the study (U2). After the end of the study, the study were treated by their family practitioners or optionally in the nephrological outpatient clinic, Klinikum rechts der Isar, Technische Universität München.
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2010-05-11
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion
P. End of Trial
P.End of Trial StatusCompleted
P.Date of the global end of the trial2014-03-18

Patrocinadores e Colaboradores

Condições médicas

Intervenções de drogas

3
Se inscrever