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    The EU Clinical Trials Register currently displays   35906   clinical trials with a EudraCT protocol, of which   5892   are clinical trials conducted with subjects less than 18 years old.
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    Summary
    EudraCT Number:2004-001500-13
    Sponsor's Protocol Code Number:A0081012
    National Competent Authority:Spain - AEMPS
    Clinical Trial Type:EEA CTA
    Trial Status:Ongoing
    Date on which this record was first entered in the EudraCT database:2005-05-09
    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 ConcernedSpain - AEMPS
    A.2EudraCT number2004-001500-13
    A.3Full title of the trial
    An 8-week, multicentre, randomised, double-blind, placebo-controlled, flexible dose study of Pregabalin (300-600 mg/day) and Venlafaxine XR (75-225 mg/day) for the acute treatment of DSM-IV Generalized Anxiety Disorder in outpatients.
    A.3.2Name or abbreviated title of the trial where available
    N/A
    A.4.1Sponsor's protocol code numberA0081012
    A.5.1ISRCTN (International Standard Randomised Controlled Trial) NumberN/A
    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 SponsorPfizer, S.A.
    B.1.3.4CountrySpain
    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 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 Lyrica
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer Limited
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    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 nameLyrica
    D.3.2Product code PD 0144723 (CI-1008)
    D.3.4Pharmaceutical form Capsule*
    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 INNPregabalin
    D.3.9.1CAS number 148553-50-8
    D.3.9.3Other descriptive name[(S)-3(aminomethyl)-5-methylhexanoic acid]
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 300
    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.IMP: 2
    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 Information not present in EudraCT
    D.2.1.1.1Trade name Trevilor Retard
    D.2.1.1.2Name of the Marketing Authorisation holderWyeth Pharma GmbH
    D.2.1.2Country which granted the Marketing AuthorisationSpain
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community Information not present in EudraCT
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameTrevilor Retard
    D.3.2Product code N/A
    D.3.4Pharmaceutical form Capsule*
    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 INNVenlafaxine Hydrochloride
    D.3.9.3Other descriptive name(R/S)-1-[2-(dimethylamino)-1-(4-methoxyphenyl) ethyl] cyclohexanol hydrochloride
    D.3.10 Strength
    D.3.10.1Concentration unit mg milligram(s)
    D.3.10.2Concentration typerange
    D.3.10.3Concentration number75 to 225
    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 placeboCapsule*
    D.8.4Route of administration of the placeboOral use
    D.8 Placebo: 2
    D.8.1Is a Placebo used in this Trial?Yes
    D.8.3Pharmaceutical form of the placeboCapsule*
    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
    Generalized Anxiety Disorder
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Version 7.0
    E.1.2Level LLT
    E.1.2Classification code 10018105
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main objective of the trial
    To evaluate the efficacy of Pregabalin and Venlafaxine XR (extended release) compared to placebo in the treatment of GAD).
    E.2.2Secondary objectives of the trial
    To evaluate onset of activity of pregabalin in comparison to placebo and venlafaxine XR in the treatment of GAD symptoms at day 4 of double-blind treatment and to evaluate, through a subject-rated global scale, the efficacy of pregabalin in decreasing GAD symptoms, on a daily basis during the first week of double blind treatment.
    To evaluate the effect of pregabalin in the treatment of GAD, on improvement in quality of life, sexual satisfaction, disability, sleep and pain.
    To evaluate the effect of pregabalin and venlafaxine XR in the treatment of depressive symptoms experienced by non-depressed patients diagnosed with GAD.
    To evaluate the safety of pregabalin and venlafaxine XR in GAD, including overall tolerability, effects on sexual functioning, discontinuations due to adverse events, and discontinuation-emergent symptoms.
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    Subjects must meet all of the following inclusion criteria to be eligible for enrollment into the trial:
    1. Signed and dated informed consent will be obtained from each subject (only include those able to consent) in accordance with the local regulatory and legal requirements.
    2. Ages 18 to 65 years.
    3. Male or female outpatient.
    4. A primary diagnosis of DSM-IV-TRTM (2000) GAD (for criteria refer to Appendix F of the protocol). GAD will be diagnosed with the MINI International Neuropsychiatric Interview (M.I.N.I) Version 5.0.0. The more detailed Module P GAD from the M.I.N.I. Plus (Version 5.0.0) will be used to assess the GAD diagnosis specifically.
    5. Hamilton Anxiety Rating Scale (HAM-A) total score > 20 and a score of > 10 on both the psychic and somatic factor scores at screening and baseline.
    6. At least 4 Global Anxiety Visual Analogue Scale assessments must be completed between screening and baseline.
    7. At least 4 Daily Pain Rating Scale assessments must be completed between screening and baseline.
    8. Screening laboratory values must be within normal limits, or abnormalities must be clinically insignificant. Liver function tests > 2 times the upper limit of normal are considered significant.
    9. Females of childbearing potential must have a negative serum b-HCG pregnancy test and be practicing an effective form of contraception (accepted methods are hormonal [oral contraceptive or injectable contraceptive], double barrier with spermicide, or intrauterine device-IUD). Complete abstinence may be considered acceptable, but must first be discussed on a case-by-case basis with the Pfizer monitor prior to any screening tests or procedures for the study.
    E.4Principal exclusion criteria
    1. Pregnant or lactating women.
    2. Hamilton Depression Rating Scale (17-item HAM-D) score > 15 or score of > 2 on item 1 (depressed mood) of HAM-D. (Refer to Appendix I of the protocol)
    3. A current DSM-IV-TRTM (2000) diagnosis of major depressive disorder, dysthymia, obsessive-compulsive disorder, posttraumatic stress disorder, body dysmorphic disorder or eating disorder at screening or within the past 6 months.
    4. DSM-IV-TRTM (2000) diagnosis of substance abuse or dependence within the last 6 months prior to screening. (Refer to Appendix G of the protocol)
    5. Mental condition, including mental retardation, rendering the individual unable to understand the nature, scope, and possible consequences of the study and/or evidence of an uncooperative attitude.
    6. A current or lifetime diagnosis of schizophrenia, or any other psychotic disorder, or bipolar disorder.
    7. A history of a seizure disorder, except febrile seizures of childhood.
    8. Creatinine clearance ≤ 60 ml/min (estimated from serum creatinine, body weight, age, and sex using the Cockroft-Gault equation (refer to Appendix E of the protocol)). Subjects who have an estimated creatinine clearance of less than 60 ml/min by this screening method may, at the investigator’s discretion, have their creatinine clearance measured with a 24-hour urine collection, performed at the central laboratory. If this 24-hour urine creatinine clearance is greater than 60 ml/min, the subject may be randomized.
    9. Receiving psychotherapy (e.g., cognitive therapy, cognitive-behavioral therapy, supportive therapy or others) in which the specific focus of the therapy is GAD and its symptoms, or another anxiety disorder. Subjects who are contemplating beginning a course of psychotherapy and/or behavioral therapy during the study. Subjects already receiving psychotherapy (unrelated to the treatment of GAD or any other anxiety disorder) for at least 3 months prior to screening may be entered, provided their therapy remains unrelated to the treatment of GAD or other anxiety disorder, and there is no change in the type of therapy, or therapist during the study.
    10. Received or have required electroconvulsive therapy within six (6) months prior to study entry.
    11. Antidepressant, anxiolytic, antipsychotic, sedative (other than zopiclone or zolpidem for insomnia), hypnotic or psychoactive drug use within 2 weeks (5 weeks for fluoxetine) prior to the baseline visit or during the study. If medication is required for the treatment of insomnia during the one-week wash-out, zopiclone (3.75 mg per night) or zolpidem (5 mg per night) may be taken intermittently (prn) on two or fewer nights until 3 days before baseline.
    12. Received depot neuroleptics within the previous 6 months of the baseline visit.
    13. All herbal psychoactive treatments within 14 days of the baseline visit.
    14. Daily and/or regular use of benzodiazepines at any dose within 4 weeks of the baseline visit.
    15. Urine screen positive for benzodiazepines at Screening and/or Baseline Visit.
    16. Requiring concomitant therapy with any psychotropic drug or drug with a psychotropic component during the course of the study (If medication is required for the treatment of insomnia during the one-week wash-out, zopiclone (3.75 mg per night) or zolpidem (5 mg per night) may be taken intermittently (prn) on two or fewer nights until 3 days before baseline.).
    17. Requiring treatment with medications other than those permitted on the concomitant medication chart (Appendix C of the protocol) at the end of the wash-out, lead-in period.
    18. Previously have been treated with venlafaxine IR, venlafaxine XR, or pregabalin (for any disorder).
    E.5 End points
    E.5.1Primary end point(s)
    The primary efficacy parameter is the Hamilton Anxiety Scale (HAM-A), which is assessed at each study visit.
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis Information not present in EudraCT
    E.6.2Prophylaxis Information not present in EudraCT
    E.6.3Therapy Information not present in EudraCT
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic Information not present in EudraCT
    E.6.7Pharmacodynamic Information not present in EudraCT
    E.6.8Bioequivalence Information not present in EudraCT
    E.6.9Dose response Information not present in EudraCT
    E.6.10Pharmacogenetic Information not present in EudraCT
    E.6.11Pharmacogenomic Information not present in EudraCT
    E.6.12Pharmacoeconomic Information not present in EudraCT
    E.6.13Others Information not present in EudraCT
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) Information not present in EudraCT
    E.7.1.1First administration to humans Information not present in EudraCT
    E.7.1.2Bioequivalence study Information not present in EudraCT
    E.7.1.3Other Information not present in EudraCT
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Information not present in EudraCT
    E.7.3Therapeutic confirmatory (Phase III) Yes
    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 Information not present in EudraCT
    E.8.1.3Single blind Information not present in EudraCT
    E.8.1.4Double blind Yes
    E.8.1.5Parallel group Information not present in EudraCT
    E.8.1.6Cross over Information not present in EudraCT
    E.8.1.7Other Information not present in EudraCT
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) Yes
    E.8.2.2Placebo Yes
    E.8.2.3Other Information not present in EudraCT
    E.8.3 The trial involves single site in the Member State concerned No
    E.8.4 The trial involves multiple sites in the Member State concerned Yes
    E.8.5The trial involves multiple Member States Yes
    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 of last subject undergoing trial
    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
    E.8.9.2In all countries concerned by the trial years1
    E.8.9.2In all countries concerned by the trial months6
    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 2005-05-09. 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.4.2.1In the EEA 390
    F.4.2.2In the whole clinical trial 390
    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)
    Normal treatment
    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 Decision2004-12-22
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-12-05
    P. End of Trial
    P.End of Trial StatusOngoing
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