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    Summary
    EudraCT Number:2011-005522-22
    Sponsor's Protocol Code Number:Rifa-BP
    National Competent Authority:Finland - Fimea
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2012-01-09
    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 ConcernedFinland - Fimea
    A.2EudraCT number2011-005522-22
    A.3Full title of the trial
    The effects of PXR activation on blood pressure regulation
    PXR-aktivaation vaikutus verenpaineen säätelyyn
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    The effects of PXR activation on blood pressure regulation
    PXR-aktivaation vaikutus verenpaineen säätelyyn
    A.3.2Name or abbreviated title of the trial where available
    Rifa-BP
    A.4.1Sponsor's protocol code numberRifa-BP
    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 SponsorOulu University Hospital, Department of Internal Medicine
    B.1.3.4CountryFinland
    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 support
    B.4.2Country
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationOulu University Hospital, Department of Internal Medicine
    B.5.2Functional name of contact pointInternal Medicine Research Lab
    B.5.3 Address:
    B.5.3.1Street AddressKajaanintie 50
    B.5.3.2Town/ cityOulu
    B.5.3.3Post code90029
    B.5.3.4CountryFinland
    B.5.4Telephone number35883155621
    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 Rimapen
    D.2.1.1.2Name of the Marketing Authorisation holderOrion Oyj
    D.2.1.2Country which granted the Marketing AuthorisationFinland
    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.3.4Pharmaceutical form Tablet
    D.3.4.1Specific paediatric formulation No
    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 INNRIFAMPICIN
    D.3.9.1CAS number 13292-46-1
    D.3.9.4EV Substance CodeSUB10309MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number600
    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 placeboTablet
    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
    Healthy volunteers
    Terveitä vapaaehtoisia
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To study how PXR activation by rifampicin affects blood pressure regulation.
    Tutkimus selvittää miten rifampisiinin aiheuttama PXR-aktivaatio vaikuttaa verenpaineen säätelyyn.
    E.2.2Secondary objectives of the trial
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    o Healthy volunteers
    o 18-40 years of age
    o Body mass index (BMI) 19-30 kg/m2
    o Systolic blood pressure 95–140 mmHg
    o Terveitä vapaaehtoisia
    o 18-40 vuotiaita
    o Painoindeksi (BMI) 19-30 kg/m2
    o Systolinen verenpaine 95–140 mmHg
    E.4Principal exclusion criteria
    o Diastolic blood pressure over 90 mmHg
    o Any continuous medication (hormonal intrauterine device is permitted)
    o Any significant medical condition
    o Insensitivity to rifampicin
    o Pregnancy and lactation
    o Previous difficult venipuncture
    o Alcohol and medicine abuse and drug use
    o Participation to any other pharmaceutical trial within on month of screening
    o Diastolinen verenpaine yli 90 mmHg
    o Säännöllinen lääkitys (hormonikierukka sallittu)
    o Merkittävät sairaudet
    o Yliherkkyys rifampisiinille
    o Raskaus ja imetys
    o Aiemmat vaikeat verinäytteen otot
    o Lääkkeiden ja alkoholin väärinkäyttö ja huumeiden käyttö
    o Osallistuminen muuhun lääketutkimukseen 1 kk sisällä ennen tutkimuksen alkua
    E.5 End points
    E.5.1Primary end point(s)
    Changes in 24-hr ambulatory systolic and diastolic blood pressure and pulse.
    Changes in office systolic and diastolic blood pressure and pulse.
    Muutokset 24h-verenpaineseurannassa (systolinen ja diastoline verenpaine ja syke).
    Muutokset verenpaineen kertamittauksissa (systolinen ja diastoline verenpaine ja syke)
    E.5.1.1Timepoint(s) of evaluation of this end point
    At the end of both arms on Day 8 after the one-week treatment.
    Jokaisen tutkimushaaran lopussa eli viikon lääkityksen jälkeen päivänä 8.
    E.5.2Secondary end point(s)
    Plasma renin activity and serum aldosterone level.
    Plasman reniiniaktiivisuus ja seerumin aldosteronitaso
    E.5.2.1Timepoint(s) of evaluation of this end point
    At the end of both arms on Day 9.
    Kummankin tutkimushaaran lopussa tutkimusjakson päivänä 9.
    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 No
    E.6.4Safety Yes
    E.6.5Efficacy No
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic Yes
    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) No
    E.7.3Therapeutic confirmatory (Phase III) No
    E.7.4Therapeutic use (Phase IV) Yes
    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 Yes
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over Yes
    E.8.1.7Other No
    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.8.2.4Number of treatment arms in the trial2
    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.8.5The 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 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 years2
    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 years2
    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.1.2.1Number of subjects for this age range: 22
    F.1.3Elderly (>=65 years) No
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers Yes
    F.3.2Patients No
    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 Yes
    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 state22
    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 Decision2012-01-12
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2012-01-23
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2013-12-31
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