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    The EU Clinical Trials Register currently displays   44155   clinical trials with a EudraCT protocol, of which   7326   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:2004-000156-16
    Sponsor's Protocol Code Number:A509 1043
    National Competent Authority:Sweden - MPA
    Clinical Trial Type:EEA CTA
    Trial Status:Prematurely Ended
    Date on which this record was first entered in the EudraCT database:2004-08-27
    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 ConcernedSweden - MPA
    A.2EudraCT number2004-000156-16
    A.3Full title of the trial
    Phase 3 multi center, double blind, randomized, parallel group evaluation of the fixed combination torcetrapib/atorvastatin, administered orally, once daily (QD), compared with atorvastatin alone, on the occurrence of major cardiovascular events in subjects with coronary heart disease or risk equivalents.
    A.4.1Sponsor's protocol code numberA509 1043
    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 AB
    B.1.3.4CountrySweden
    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.2.5The 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 nameTorcetrapib/Atorvastatin
    D.3.2Product code CP-519,414/Atorvastatin
    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.3.11 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 Atorvastatin
    D.2.1.1.2Name of the Marketing Authorisation holderPfizer AB
    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 nameLipitor
    D.3.2Product code N/A
    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.3.11 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 placeboTablet
    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 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
    Coronary Heart Disease
    MedDRA Classification
    E.1.2 Medical condition or disease under investigation
    E.1.2Classification code 10011078
    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 clinical trial is to demonstrate whether or not the fixed combination torcetrapib/atorvastatin, can incrementally reduce the risk for future occurrence of major cardiovascular disease events (MCVE), when compared to atorvastatin alone, in subjects with coronary heart disease (CHD) or risk equivalents.
    E.2.2Secondary objectives of the trial
    Secondary objectives will include examining the effect of torcetrapib/atorvastatin over that of atorvastatin alone on the following:
    1. The time to first occurrence of the following clinical endpoints:·
    Major CHD events composite (defined as CHD death and nonfatal MI)·
    MCVE, coronary revascularization procedures, and PVD composite·
    Stroke (fatal and nonfatal) and (TIA) composite·
    Major CHD events, stroke (fatal and nonfatal), and TIA composite·
    All cause mortality
    2. Change from baseline in LDL-C and HDL-C
    E.2.3Trial contains a sub-study Information not present in EudraCT
    E.3Principal inclusion criteria
    1.Subjects with high risk of CVD events defined as any of the following:
    a. Prior myocardial infarction in which the most recent event occurred 1 month (30 days) to 60 months prior to the screening visit.
    b. Previous cardiac revascularization procedure prior to screening (see protocol for more details)
    c. Pre existing atherosclerotic CHD (documented acute coronary syndrome including unstable angina) in which the most recent event occurred 1 month (30 days) to 60 months prior to the screening visit. (see protocol for more details)
    d. Pre existing symptomatic carotid artery disease (documented prior stroke defined as persistent brain deficit lasting more than 24 hours with a demonstrable lesion by CT or MRI scan) at least one month (30 days) prior to screening.
    e. Pre existing PVD; documented as either a peripheral intervention [at least one month (30 days) prior to screening] or ankle/brachial index (ABI) <0.9.
    f. Prior diagnosis of type 2 diabetes including subjects currently on hypoglycemic agents or insulin, and/or according to American Diabetes Association (ADA) criteria.

    2. Subjects eligible for statin (HMG CoA reductase inhibitor) treatment defined as:
    a. On a statin or other prescription lipid altering treatment at screening, or
    b. LDL C ³100 mg/dL (2.6 mmol/L) if not on a prescription lipid altering treatment at screening.
    E.4Principal exclusion criteria
    1. Women who are pregnant, lactating, or who are planning to become pregnant Women of childbearing potential who have not successfully been using acceptable contraceptive methods over the previous 3 months (eg, hormonal contraception, intrauterine device, barrier method plus spermicide).
    2. Subjects at Visit 1 who are not on prior prescription lipid-altering treatment, and have an LDL C of <100 mg/dL (2.6 mmol/L).
    3. Subjects who at the final atorvastatin only run in visit (ie, subjects are on 80 mg atorvastatin daily), fail to reach the target LDL C of <100 mg/dL (2.6 mmol/L)
    4. Subjects who have participated in long term (³3 years) cardiovascular endpoint trials anytime within the 12 months prior to screening/Visit 1.
    5. Subjects or are planned after randomization a coronary angioplasty, CABG, other cardiovascular surgery (eg, valve replacement), or other peripheral intervention; or experiencing a CVD event (eg, MI, stroke) within 30 days (exclusive) of the screening visit or during the atorvastatin only run in period.
    6. Subjects with severe pre existing CHD that limits their expected ability to complete the trial or their life expectancy (please see protocol for further details).
    7. Subjects with uncontrolled hypertension, defined as an average SBP >140 mmHg or an average diastolic blood pressure (DBP) >90 mmHg, at baseline. Subjects with an average SBP >140 mmHg or DBP >90 mmHg at screening or any run in visit (Visits 2 6) should receive appropriate treatment for hypertension.
    8. Fasting triglycerides >500 mg/dL (5.6 mmol/L) at Visit 1 or 2.
    9. Subjects receiving the following concomitant lipid-altering therapy ( non statins and statins) or therapies affecting LDL-C, HDL-C and TG at Visit 1:
    10. Subjects taking any drugs known to be associated with an increased risk of myositis in combination with HMG CoA reductase inhibitors.
    11. Subjects with any other medical condition or laboratory abnormality prior to randomization, which in the opinion of the principal investigator could affect subject safety, preclude evaluation of response, or render unlikely that the subject would complete the study, including but not limited to:
    a. Subjects with uncontrolled diabetes mellitus;
    b. Subjects with renal disease
    c. Subjects with uncontrolled hypothyroidism defined as a TSH >2 times the ULRR at Visit 1;
    d. Subjects with any active hepatobiliary disease (including cirrhosis), serologic evidence of past or active hepatitis B or hepatitis C infection, or an AST or ALT >2 times the ULRR, alkaline phosphatase >1.5 times the ULRR with elevated liver isoform of alkaline phosphatase or total bilirubin >1.5 times the ULRR at Visit 1 or 2;
    e. Subjects with unexplained serum CK >3 times the ULRR at Visit 1 or 2 (eg, not due to recent trauma, intramuscular injections, heavy exercise). A repeat CK >3 times ULRR in the absence of conditions explaining CK elevation is exclusionary;
    f. Subjects with any prior history of malignancy.
    g. Subjects with gastrointestinal disease limiting drug absorption or partial ileal bypass, gastric stapling, or gastric binding;
    h. Subjects with alcohol and/or any other drug abuse or dependence.
    E.5 End points
    E.5.1Primary end point(s)
    Time to first occurrence of an MCVE defined as:·
    CHD death,·
    Nonfatal myocardial infarction (MI), or·
    Stroke (fatal and nonfatal)
    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 Yes
    E.6.4Safety Yes
    E.6.5Efficacy Information not present in EudraCT
    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 No
    E.8.1.3Single blind No
    E.8.1.4Double blind Yes
    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 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 Yes
    E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
    E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
    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
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years6
    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 years6
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 Information not present in EudraCT
    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) 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 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 2004-08-27. 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 state
    F.4.2 For a multinational trial
    F.4.2.2In the whole clinical trial 13000
    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)
    Details provided in protocol
    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 Decision2004-09-14
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2004-07-01
    P. End of Trial
    P.End of Trial StatusPrematurely Ended
    P.Date of the global end of the trial2006-12-02
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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