Страница клинических исследований Nct

Summary
EudraCT Number:2006-005239-32
Sponsor's Protocol Code Number:PDE5
National Competent Authority:Sweden - MPA
Clinical Trial Type:EEA CTA
Trial Status:Ongoing
Date on which this record was first entered in the EudraCT database:2006-10-18
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 ConcernedSweden - MPA
A.2EudraCT number2006-005239-32
A.3Full title of the trial
Fosfodiesterashämmares akuta hemodynamiska effekter vid pulmonell hypertension och utvärdering av kväveoxid mätningar som icke-invasiv diagnostisk metod
A.3.2Name or abbreviated title of the trial where available
PH-patienter och PDE5
A.4.1Sponsor's protocol code numberPDE5
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 SponsorMedical Sciences, Akademiska sjukhuset
B.1.3.4CountrySweden
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 organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleComparator
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 Revatio Cialis Levitra
D.2.1.1.2Name of the Marketing Authorisation holderPfizer, Lilly, Bayer
D.2.5The IMP has been designated in this indication as an orphan drug in the Community Yes
D.2.5.1Orphan drug designation numberEU/3/03/178
D.3 Description of the IMP
D.3.4Pharmaceutical form 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 INNsildenafil
D.3.9.1CAS number 139755-83-2
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNtadalafil
D.3.9.1CAS number 171596-29-5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNvardenafil
D.3.9.1CAS number 224785-90-4
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) Information not present in EudraCT
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 Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
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 Information not present in EudraCT
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
 Pulmonell hypertension med kvarstående förhöjt medeltryck i arteria pulmonalis överstigande 25 mmHg i vila eller >30 mmHg under ansträngning vid hjärtkateterisering definierad av National Institute of Health (NIH).
 Patienten skriver på för skriftligt samtycke (Informed Consent)
 Patienten över 18 år
MedDRA Classification
E.1.3Condition being studied is a rare disease Yes
E.2 Objective of the trial
E.2.1Main objective of the trial
Primärt syfte
Att studera de akuta hemodynamiska effekterna av olika fosfodiesterashämmare (sildenafil 20 eller 80 mg, vardenafil 20 mg eller tadalafil 10 eller 40 mg) givet till patienter med pulmonell hypertension isamband med hjärtkateterisering.
E.2.2Secondary objectives of the trial
(1) Att jämföra de akuta hemodynamiska effekterna av olika fosfodiesterashämmare (sildenafil 20 eller 80 mg, vardenafil 20 mg eller tadalafil 10 eller 40 mg) i samband med hjärtkateterisering
(2) Att relatera de akuta hemodynamiska effekterna till uppmätt koncentration av fosfodisterashämmare i blod under hjärtkateteriseringstillfället
(3) Att studera farmakokinetiken upp till 24 timmar efter en dos fosfodiesterashämmare
(4) Att studera eventuell effekt på NO- och kolmonxidutsöndring efter intag
av fosfodiesterashämmare.
(5) Att relatera halten av utandad NOoch kolmonoxid, samt halterna av NO-nedbrytningsprodukter (nitrat/nitrit) i saliv och blod till hemodynamiska data från hjärtkateteriseringstillfället, dvs tryck och flöden i lungkretsloppet.
(6) Att studera ADMA i blod och relatera halten dels till hemodynamiska data från hjärtkateteriseringstillfället samt till halterna av NO i utandningsluft och NO-nedbrytningsprodukter i saliv och blod.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
 Pulmonell hypertension med kvarstående förhöjt medeltryck i arteria pulmonalis överstigande 25 mmHg i vila eller >30 mmHg under ansträngning vid hjärtkateterisering definierad av National Institute of Health (NIH).
 Patienten skriver på för skriftligt samtycke (Informed Consent)
 Patienten över 18 år
E.4Principal exclusion criteria
6.2.2 Exklusionskriterier
Försökspersonerna exkluderas ur studien om något av följande kriterier inte uppfylls:

 Patient stående på kronisk behandling av fosfodiesterashämmare som ej varit behandlingsfri från fosfodiesterashämmare de senaste två veckorna.
 Kontraindikation vid behandling med ritonavir, indinavir, Class I och class III antiarytmika.
 Patient med HIV stående på ritonavir eller indinavir.
 Allergi mot någon av testsubstanserna eller något av innehållsämnena.
 Gravid eller ammande kvinna
 Patienter som använder orala preventivmedel.
 Svår leverfunktionsnedsättning (Child-Pugh klass C)
 Tidigare icke arteritisk främre ischemisk optikusinfarkt/neuropati (NAION)
 Svår hypotension (blodtryck < 90/50 mmHg) vid behandlingsstart
E.5 End points
E.5.1Primary end point(s)
 Tryck i den lungartär (PA) som utgår från höger kammare, studeras under hjärtkateterisering.
 Pulmonell vaskulär resistens, PVR
 Systemisk vaskulär resistens, SVR
 PVR/SVR
 Koncentrationer av fosfodiesterashämmare i blodet
 Halten NO och kolmonoxid vid utandning.
 Koncentrationen av NO-nedbrytningsprodukter (nitrat/nitrit) i blod och saliv
 Koncentration av ADMA i plasma.
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis Yes
E.6.2Prophylaxis No
E.6.3Therapy Yes
E.6.4Safety No
E.6.5Efficacy Yes
E.6.6Pharmacokinetic Yes
E.6.7Pharmacodynamic Yes
E.6.8Bioequivalence No
E.6.9Dose response Yes
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 Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
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 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 Information not present in EudraCT
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
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 Yes
F.3.3.1Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-10-18. Yes
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 state50
F.4.2 For a multinational trial
F.4.2.2In the whole clinical trial 50
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)
Efter studiens slut fortsätter vi att följa upp och behandla de diagnostiserade patienterna enligt gängse rutiner vid kardiologkliniken och reumatologkliniken. De kommer även att följas upp med mätningar av utandat NO- och kolmonoxid, liksom bestämning av ADMA i blod och nitrit/nitrat-mätning från blod och saliv var 3:e månad upp till 24 månader.
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 Decision2006-11-16
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2006-11-28
P. End of Trial
P.End of Trial StatusOngoing

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться