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    The EU Clinical Trials Register currently displays   38003   clinical trials with a EudraCT protocol, of which   6235   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2013-004866-33
    Sponsor's Protocol Code Number:CA-BP13
    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:2014-01-29
    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
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedSweden - MPA
    A.2EudraCT number2013-004866-33
    A.3Full title of the trial
    A short term open, randomized cross over trial trial exploring the effect of carbonic anhydrase inhibition by acetazolamide on sleep apnea associated hypertension
    Blodtryckssänkande effekten av karbanhydrashämning hos patienter med sömnapnérelaterad hypertension.
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    A short term open, randomized cross over trial trial exploring the effect of carbonic anhydrase inhibition by acetazolamide on sleep apnea associated hypertension
    Blodtryckssänkande effekten av karbanhydrashämning hos patienter med sömnapnérelaterad hypertension.
    A.3.2Name or abbreviated title of the trial where available
    carbonic anhydrase inhibition- sleep apnea associated hypertension
    karbanhydrashämning -sömnapnérelaterad hypertension
    A.4.1Sponsor's protocol code numberCA-BP13
    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 SponsorGöteborgs Universitet
    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 supportGöteborgs Universitet
    B.4.2CountrySweden
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationGöteborgs Universitet
    B.5.2Functional name of contact pointJan Hedner
    B.5.3 Address:
    B.5.3.1Street AddressMedicinaregatan 8b
    B.5.3.2Town/ cityGöteborg
    B.5.3.3Post code40530
    B.5.3.4CountrySweden
    B.5.4Telephone number+46(0)3134210007199
    B.5.6E-mailjan.hedner@lungall.gu.se
    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 DIamox
    D.2.1.1.2Name of the Marketing Authorisation holderMercury Pharmaceuticals Ltd , No 1 Croydon, 12-16 Addiscombe Road , Croydon CR0 0XT, Storbritannien
    D.2.1.2Country which granted the Marketing AuthorisationSweden
    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 nameDiamox
    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 INNAcetazolamide
    D.3.9.1CAS number 59-66-5
    D.3.9.3Other descriptive nameACETAZOLAMIDE
    D.3.9.4EV Substance CodeSUB05219MIG
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number750
    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
    obstructive sleep apnea related hypertension
    obstruktiv sömnapné relaterad hypertension
    E.1.1.1Medical condition in easily understood language
    obstructive sleep apnea related hypertension
    obstruktiv sömnapné relaterad hypertension
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 16.1
    E.1.2Level LLT
    E.1.2Classification code 10055577
    E.1.2Term Obstructive sleep apnea syndrome
    E.1.2System Organ Class 100000004855
    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 objective of this study is to use the enzyme carbonic anhydrase (CA) well known properties in order to create a physiological condition in order to explore and compare the efficacy of pharmacological CA inhibition on obstructive sleep apnea (OSA) related hypertension. Multiple aspects of vascular function and blood pressure control will be investigated in 12 male patients, using non-invasive methods, before and after short-term treatment of the carbonic anhydrase system (by acetazolamide (ACZ), continuous positive airway pressure (nCPAP) and nCPAP plus ACZ
    I aktuell studie är syftet att utnyttja enzymet karbanhydras kända egenskaper för att skapa ett fysiologiskt tillstånd i syfte att studera och jämföra effekten av farmakologisk karbanhydrashämning hos patienter med OSA-relaterad hypertoni. Försökspersonerna kommer att undersökas med avseende på blodtryck, hemodynamiska samt sömnapné-variabler, före och efter behandling med acetazolamid, CPAP (kontinuerlig luftvägsövertryck, konventionell behandling av OSA) samt CPAP och acetazolamid genom icke- invasiva tester.
    E.2.2Secondary objectives of the trial
    The secondary objective is to investigate the direct effect of CA inhibition on sleep disordered breathing.
    Sekundärt vill vi även undersöka effekten av karbanhydrashämning på sömnapné.
    E.2.3Trial contains a sub-study No
    E.3Principal inclusion criteria
    1. Provision of informed consent prior to any study specific procedures
    2. Males 18 to 75 years
    3. An Apnea-Hypopnea Index (AHI)>15 and an Epworth Sleepiness Scale score (ESS)>6 as verified by a PSG recording.
    4. Patients with established hypertension (systolic/diastolic blood pressure >= 160/95, either systolic or diastolic accounted for).
    5. Clinically normal physical findings and laboratory values, as judged by the investigator
    6. Body mass index >= 35 kg/m2
    E.4Principal exclusion criteria
    1. Hypersensitivity to sulfonamides or acetazolamide.
    2. Patients with ongoing medication with other sulphonamides or patients any specific antihypertensive treatment.
    3. History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity.
    4. Subjects with a seizure disorder.
    5. Patients with clinically verified central sleep apnea.
    6. Clinically significant renal (serum creatinine >2.0 mg/dL or >130 mol/L), neurological, metabolic (e.g. Type 1 or 2 diabetes), haematological or hepatic disease (ASAT or ALAT >2 times the upper limit of normal).
    7. Subjects with an occupational risk potentially exaggerated by daytime sleepiness such as handling complex machinery or professional driving.
    8. Unstable angina pectoris, unstable hypertension (or poorly controlled diabetes (HbA1C < 52 mmoles/mol, or fasting plasma glucose >7 mmoles/l).
    9. Clinically significant congestive heart failure.
    10. Myocardial infarction or coronary vessel intervention within the previous 6 months period.
    11. Subjects with uncontrolled hypertension (defined as a diastolic blood pressure 110 mmHg and/or a systolic blood pressure ≥180 mmHg with or without medication).
    12. Previously diagnosed or treated clinically significant cardiac arrhythmia.
    13. Clinically significant chronic pulmonary or gastrointestinal disease.
    14. Clinical history of depression as judged by the investigator or other previous or present clinically significant psychiatric disease.
    15. Suspected or confirmed poor compliance.
    16. Alcohol or drug abuse during the last year.
    17. Subjects with any other significant condition that, in the opinion of the investigator, could interfere with participation in the study.
    18. Severe nocturnal hypoxia defined as more than 10 episodes with an oxygen desaturation exceeding 50% or signs of lacking resaturation between desaturations on previous recordings according to investigators judgment.
    19. Participation in another clinical study during the last 6 months-
    20. Inability to understand and complete the questionnaires.
    E.5 End points
    E.5.1Primary end point(s)
    The primary endpoint will be expressed in terms systolic and diastolic blood pressure (resting office, provoked office and 24 hour) as well as in various terms of vascular function (overnight vascular stiffness, heart rate variability and hypoxic vascular responsiveness) when comparing the acetazolamide to the nCPAP plus acetazolamide treatment regimen.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The total study period is 10 weeks. Endpoint will be evaluated between baseline (0 weeks) and at end of each treatment period. Each treatment period is 2 weeks with a wash-out period between treatment regimens.
    E.5.2Secondary end point(s)
    The change in sleep disordered breathing variables such as Apnea-Hypopnea index score (AHI), oxygen desaturation index (ODI), mean overnight oxygenation, and sleep quality, daytime sleepiness, patient-reported outcomes, and effects on metabolic markers when comparing treatment regimens.
    E.5.2.1Timepoint(s) of evaluation of this end point
    The total study period is 10 weeks. Endpoint will be evaluated between baseline (0 weeks) and at end of each treatment period. Each treatment period is 2 weeks with a wash-out period between treatment regimens.
    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 No
    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 Yes
    E.6.13.1Other scope of the trial description
    This is a hypothesis-generating research study, a methodological study.
    Detta är en hypotes-genererande och metodologisk studie.
    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) No
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled Yes
    E.8.1.1Randomised Yes
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    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 No
    E.8.2.3Other Yes
    E.8.2.3.1Comparator description
    Continuous positive airway pressure (CPAP), and CPAP plus acetazolamide.
    E.8.2.4Number of treatment arms in the trial3
    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
    Study is defined as complete ("end of study") when the last patient completes the final study day.
    Studien definieras som klar ("slut") när den sista patienten genomgått sista studiedagen.
    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
    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: 9
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 3
    F.2 Gender
    F.2.1Female No
    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 state12
    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)
    Patients will be followed up according to clinical routines within the health sector after the study is completed.
    Patienterna kommer efter att de blivit avslutad i studien att behandlas på sedvanligt sätt enligt kliniska rutiner inom sjuk-och hälsovården.
    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 Decision2014-03-27
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2014-04-04
    P. End of Trial
    P.End of Trial StatusOngoing
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