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    The EU Clinical Trials Register currently displays   43845   clinical trials with a EudraCT protocol, of which   7282   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

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    Summary
    EudraCT Number:2005-000295-41
    Sponsor's Protocol Code Number:Ro-002/05
    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:2005-12-20
    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 ConcernedGermany - BfArM
    A.2EudraCT number2005-000295-41
    A.3Full title of the trial
    Double-blind,placebo-controlled cross-over study for evaluation of the efficacy of the PDE-5-inhibitor vardenafil on the peripheral perfusion and the clinical symptomatology of patients with Raynaud´s disease.
    A.4.1Sponsor's protocol code numberRo-002/05
    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 SponsorUniversität zu Köln
    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 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 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 Information not present in EudraCT
    D.2.1.1.1Trade name Levitra 10 mg Filmtabletten
    D.2.1.1.2Name of the Marketing Authorisation holderBayer AG
    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 nameVardenafil
    D.3.2Product code Bay 38-9456
    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 INNVardenafil
    D.3.9.1CAS number 224785-91-5
    D.3.9.2Current sponsor codeBay 38-9456
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typeequal
    D.3.10.3Concentration number10
    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 Information not present in EudraCT
    D.3.11.8Extractive medicinal product Information not present in EudraCT
    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
    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
    Raynaud´s disease (RD) is defined as episodic, painful, cold- or emotional stress-triggered vasospasms of the digital arteries and precapillary arterioles for up to 30 minutes with or without underlying disease, leading to ischemia of the fingers
    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
    The main objectives of the study are to evaluate the efficacy of vardenafil in comparison to placebo on (i) the digital perfusion (laser flux Doppler) and (ii) the clinical symptoms (Raynaud Condition Score) of patients suffering from Raynaud´s disease.
    E.2.2Secondary objectives of the trial
    Adverse Events.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    - Diagnosis of Raynaud´s Disease (primary and secondary) for > 1 year
    - Age between 18 and 65 years
    - documented written informed consent
    E.4Principal exclusion criteria
    a. Previous or Current Medical Conditions
    Any unstable medical, psychiatric, or substance abuse disorder that in the opinion of the Investigator is likely to affect the patient's ability to complete the study or precludes the patient’s participation in the study.
    Known contraindications for PDE-5 inhibitors (e.g. hypersensitivity, nitrate therapy, relevant CYP3A4-inhibitors, etc.)
    Necrosis of the finger tips
    Retinitis pigmentosa.
    History of positive test for Hepatitis B surface antigen (HbsAg) or Hepatitis C.
    Unstable angina pectoris.
    Severe congestive heart failure (NYHA stages III or IV).
    History of myocardial infarction, stroke or life-threatening arrhythmia within 6 months prior to Visit 1.
    Uncontrolled atrial fibrillation/flutter at Visit 1 (ventricular response rate > 100 beats per minute).
    Prolonged QTc-time (> 450 msec)
    Congenital Long-QT-Syndrom
    Hypopotassemia
    Severe chronic or acute liver disease.
    Clinically significant chronic hematological disease which may lead to priapism such as sickle cell anemia and leukemia.
    Bleeding disorder.
    Significant active peptic ulceration.
    Resting hypotension (a resting systolic blood pressure of <90 mm Hg) or hypertension (a resting systolic blood pressure >170 mm Hg or a resting diastolic blood pressure >110 mm Hg).
    History of malignancy within the past 5 years (other than squamous or basal cell skin cancer).
    Patients with spinal lessions or known CNS-diseases
    Patients known to have or have had severe renal impairment (creatinine clearance < 30 ml).
    Patients known to suffer from mild to severe hepatic impairment (Child-Pugh A-C).
    Patients under 18 or above 80 years of age

    b. Concomitant Medication
    All drugs that are taken in addition to the study drug during the course of the study are considered as concomitant medication. The use of any concomitant medication must be documented. The following concomitant medications are NOT allowed:
    Nitrates or nitric oxide donors.
    Androgens (e.g. testosterone).
    Anti-androgens.
    Anticoagulants, except for antiplatelet agents.
    Patients who are taking the following inhibitors of cytochrome P 450 3A4: very potent HIV protease inhibitors (ritonavir, indinavir), the anti-mycotic agents itraconazole and ketoconazole (topical preparations are allowed) or erythromycin.
    Patients who have received any investigational drug (including placebo) within 30 days of Visit 1.
    Subjects who are taking nebivolol
    Subjects who are taking alpha-blockers
    Subjects who are taking Calcium-Chanel-Blockers

    c. Abnormal Laboratory Values
    Serum creatinine > 3 mg/dl at visit 1.
    Elevation of GOT / GPT to > 3 x upper limit
    Uncontrolled Diabetes mellitus (HbA1c > 9%)

    d. Other exclusion criteria
    Patients unwilling to cease use of vacuum devices, intracavernosal injection, Viagra or other therapy for erectile dysfunction for the entire course of the study.
    History within the last 6 months of severe migraine headaches occurring once monthly or more frequently (a patient with a history of migraine headaches that are now well controlled on medication is acceptable for enrollment).
    Known hypersensitivity to any component of the investigational medication.
    Patients who are illiterate or are unable to understand the language in which the questionnaires or patient diary are available.
    Subjects unwilling to refrain from consuming grapefruit juice or products containing grapefruit juice with study medication.
    Pregnancy or breast feeding (pregancy test before enrollment).
    Female patients, in whom an effective contraceptive therapy is not ensured (solely oral contraception not sufficient, high-effective methods of contraception must be applied with a predictive value < 1%/year, barriers: implants, intrauterine-devices (IUDs), diaphragmas, condoms, promescuity, vasectomied partners, spermizides).
    Patients who are, at the time point of inclusion or have been within 30 days, participating in another interventionel study
    E.5 End points
    E.5.1Primary end point(s)
    Peripheral perfusion as measured by Laser-Flux-Doppler Sonography at room temperature and cold exposure; Clinical outcome (Raynaud Condition Score)
    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 Information not present in EudraCT
    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) Yes
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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.8.3 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 Information not present in EudraCT
    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
    last visit.
    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 months6
    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 Information not present in EudraCT
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
    F.1.1.3Newborns (0-27 days) Information not present in EudraCT
    F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
    F.1.1.5Children (2-11years) Information not present in EudraCT
    F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
    F.1.2Adults (18-64 years) Yes
    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 No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Information not present in EudraCT
    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 2005-12-20. Yes
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    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 state60
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 60
    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)
    After study drug/placebo treatment has ended further treatment of the patients will remain under the investigator´s responsibility and he should act according to medical standards for this kind of patients.
    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 Decision2006-05-29
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2006-01-25
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2010-04-07
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