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    Summary
    EudraCT Number:2008-000581-23
    Sponsor's Protocol Code Number:CSPP100A2244
    National Competent Authority:Denmark - DHMA
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2008-07-04
    Trial results View 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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedDenmark - DHMA
    A.2EudraCT number2008-000581-23
    A.3Full title of the trial
    A randomized, double-masked, placebo-controlled add on study to assess the efficacy of oral aliskiren 300 mg once daily for diabetic macular edema
    Et randomiseret, dobbeltblindet placebo kontrolleret, add-on forsøg til vurdering af effekten af peroral aliskiren 300 mg én gang dagligt til behandling af diabetisk makulaødem
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Et randomiseret, dobbeltblindet placebo kontrolleret, add-on forsøg til vurdering af effekten af peroral aliskiren 300 mg én gang dagligt til behandling af diabetisk makulaødem
    A.4.1Sponsor's protocol code numberCSPP100A2244
    A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorNovartis Pharma AG
    B.1.3.4CountrySwitzerland
    B.3.1 and B.3.2Status of the sponsorCommercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationNovartis Healthcare A/S
    B.5.2Functional name of contact point
    B.5.3.4CountryDenmark
    B.5.6E-mailskriv.til@novartis.com
    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 300mg film-coated tablets
    D.2.1.1.2Name of the Marketing Authorisation holderNovartis Europharm Limited
    D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
    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 nameRasliez
    D.3.2Product code SPP100
    D.3.4Pharmaceutical form Film-coated tablet
    D.3.4.1Specific paediatric formulation Information not present in EudraCT
    D.3.7Routes of administration for this IMPOral use
    D.3.8 to D.3.10 IMP Identification Details (Active Substances)
    D.3.8INN - Proposed INNALISKIREN
    D.3.9.1CAS number 173334-57-1
    D.3.9.2Current sponsor codeSPP100
    D.3.9.3Other descriptive nameTekturna
    D.3.9.4EV Substance CodeSUB21380
    D.3.10 Strength
    D.3.10.3Concentration number300 mg
    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
    D.8 Placebo: 1
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboFilm-coated tablet
    D.8.4Route of administration of the placeboOral use
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    Diabetic Macular Edema (DME) in hypertensive patients
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 19.0
    E.1.2Level LLT
    E.1.2Classification code 10057915
    E.1.2Term Diabetic macular oedema
    E.1.2System Organ Class 100000004853
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To assess the effect of aliskiren compared to placebo on change in central retina thickness (CRT), measured by
    optical coherence tomography (OCT), from the baseline thickness in patients with type 1 or type 2 diabetes, after
    12 weeks of treatment.
    E.2.2Secondary objectives of the trial
    To assess the effect of aliskiren on BCVA in terms of change from baseline in no. of letters correctly identified at
    12 weeks;-on BCVA in terms of the proportion of patients with a ≥ 15 letter gain or loss on BCVA at 12 weeks
    from baseline.
    To investigate relationship between change in macular edema and change in the RAS and angiogenic biomarkers.
    To assess effect of aliskiren on the percent of change in central retina thickness measured by optical coherence
    tomography from the baseline thickness that is above the lower limit of normal retina thickness in patients with
    type 1 or type 2 diabetes, after 12 weeks of treatment.
    To assess effect of aliskiren on change from baseline in central retinal thickness in terms of the proportion of
    patients with a ≥ 75 micron decrease in CRT or a return to normal CRT, defined as no evidence of DME on OCT
    and a CRT of ≤ 245 microns at 12 weeks from baseline.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1.Male and female patients age 18 to 85 years of age inclusive, with type 1 or type 2 diabetes that is actively
    managed by a physician with hemoglobin A1C that is < or = to 10 (at screening).
    2.Macular edema with average retinal thickness measured at the central subfield (by OCT) to be ≥ 280 um.
    3.Ocular media and pupil dilation sufficient to allow fundus photography.
    4.In the judgment of the study ophthalmologist, it is safe to withhold treatment of either eye with laser
    photocoagulation, intra-vitreal steroid injection, or intra-vitreal VEGF inhibitor for the duration of the study.
    5.At Screening, and Baseline, vital signs (systolic and diastolic blood pressure and pulse rate) will be assessed
    in the sitting position after the patient has rested for at least three (3) minutes. Vital signs should be within the
    following ranges:
    body temperature between 35.0-37.5 °C
    systolic blood pressure, 90-150 mm Hg
    diastolic blood pressure, 50-95 mm Hg
    pulse rate, 40 - 90 bpm
    E.4Principal exclusion criteria
    1. Macular atrophy/scarring/fibrosis, or exudates in the study eye that would preclude
    improvement in visual acuity.
    2. Media opacity in the study eye of sufficient severity to interfere with detection of a 3 line
    improvement in acuity compared to baseline.
    3. Any progressive disease of the retina (e.g. uveitis, rod-cone dystrophy) or optic nerve (e.g.
    glaucoma) other than diabetic retinopathy.
    4. Proliferative diabetic retinopathy or severe preproliferative diabetic retinopathy in the
    study eye that should, in the opinion of the investigator, be treated by photocoagulation
    within 16 weeks of the screening visit.
    5. Intra-ocular pressure > 25 mmHg (Goldman applanation) in either eye at screening.
    6. Best corrected visual acuity worse than 20/320 in the study eye at screening or baseline.
    7. Prior intra-ocular surgery in the study eye with the exception of uncomplicated cataract
    extraction more than 6 months prior to screening.
    8. Laser photocoagulation in the study eye within three months prior to baseline.
    9. Previous treatment with an intra-vitreal VEGF inhibitor or an intra-vitreal corticosteroid in
    the study eye within 6 months prior to screening.
    10. Treatment with a topical or oral carbonic-anhydrase inhibitor within one month prior to
    baseline.
    11. Current use of or likely need for systemic medications known to be toxic to the lens,
    retina, or optic nerve (e.g., deferoxamine, hydrochloroquine, ethambutaol).
    12. Patients with estimated glomerular filtration rate (GFR) < 50 ml/min (MDRD formula) at
    screening.
    13. Plasma/serum potassium > 5.0 mmol/L at screening.
    14. Any episodes of clinically significant hypoglycemia requiring medical intervention/
    hospitalization within 3 months prior to screening.
    15. 2 or more episodes of ketoacidosis within one year of screening. Patients with the latest
    episode of ketoacidosis within 3 months of screening will be excluded.
    16. For normotensive patients, any history of clinically significant hypotension requiring
    medical attention within 12 months prior to screening.
    17. Patients with heart failure NYHA class II-IV.
    18. History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary
    intervention (PCI) within 6 months prior to screening.
    19. Second or third degree heart block without a pacemaker.
    Novartis Confidential Page 31
    Protocol Amendment No. 4 Protocol No. CSPP100A2244
    20. History or presence of cardiac arrhythmia within 6 months prior to screening that required
    antiarrhythmic drugs therapy.
    21. Clinically significant valvular heart disease
    22. Stroke within the 12 months prior to screening.
    23. History of drug allergy or intolerance to aliskiren.
    24. History of angioedema from ACE inhibitors, ARBs, or aliskiren therapy.
    25. Patients with clinically significant thyroid dysfunction not controlled by any medications.
    E.5 End points
    E.5.1Primary end point(s)
    change in central retina thickness from baseline thickness in patients with hypertension and type 1 and 2 diabetes
    after 12 weeks treatment
    change on BCVA - change from baseline in no of letters; with a ≥ 15 letter gain or loss on the BCVA at 12 weeks
    from baseline
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    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) Yes
    E.7.3Therapeutic confirmatory (Phase III) Information not present in EudraCT
    E.7.4Therapeutic use (Phase IV) Information not present in EudraCT
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open No
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group No
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Yes
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo Yes
    E.8.2.3Other No
    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 Yes
    E.8.4.1Number of sites anticipated in Member State concerned2
    E.8.5The trial involves multiple Member States No
    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 Yes
    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
    Study termination: 12 week treatment duration to detect possible therapeutic effect of aliskiren
    The study will be terminated if an unexpectedly high rate of adverse effects on renal function, blood pressure, or
    diabetic retinopathy is observed in study patients
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years
    E.8.9.1In the Member State concerned months12
    E.8.9.1In the Member State concerned days
    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 Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Information not present in EudraCT
    F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state110
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 110
    G. Investigator Networks to be involved in the Trial
    G.4 Investigator Network to be involved in the Trial: 1
    G.4.1Name of Organisation AcroNordic A/S
    G.4.3.4Network Country Denmark
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2008-07-17
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2008-07-28
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2011-02-03
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