Study for the Treatment of Transfusional Iron Overload in Myelodysplastic Patients

Sponsor
Novartis Pharmaceuticals (Industry)
Overall Status
Completed
CT.gov ID
NCT00117507
Collaborator
(none)
24
Enrollment
3
Locations
1
Arm
28
Duration (Months)
8
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Thirty patients were to be enrolled and 24 patients were actually enrolled into this open-label, single-arm trial designed to assess the safety and tolerability of oral deferasirox in adult transfusion dependent myelodysplastic syndrome (MDS) patients with iron overload. Patients enrolled in this study had low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria. All patients initiated treatment with 20mg/kg/day deferasirox.

Deferasirox were administered orally once per day for 12 months.

Condition or DiseaseIntervention/TreatmentPhase
Phase 4

Detailed Description

Patients were screened for eligibility to determine if they meet all inclusion/exclusion criteria. The screening period were up to 4 weeks. Patient's baseline LIC will be determined non-invasively by means of MRI R2 analysis. In addition, blood and urine samples will be taken for the determination of baseline safety data.

Study Design

Study Type:
Interventional
Actual Enrollment :
24 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label, Safety and Tolerability Study of Deferasirox for Treatment of Transfusional Iron Overload in Low-Risk and INT-1 Myelodysplastic Patients
Study Start Date :
Sep 1, 2005
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

ArmIntervention/Treatment
Experimental: Deferasirox

Participants received deferasirox 20mg/kg/day OD for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.

Drug: Deferasirox
Other Names:
  • Chelator
  • Iron chelator
  • Outcome Measures

    Primary Outcome Measures

    1. Number of Participants With Adverse Events and Serious Adverse Events [Up To Week 52]

      An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment.

    Secondary Outcome Measures

    1. Absolute Change in Serum Ferritin From Baseline to Week 52 [Baseline to Week 52]

      Absolute change in serum ferritin after start of treatment with Deferasirox (ICL670).

    2. Absolute Change in Liver Iron Concentration (LIC) From Baseline to End of Study [Baseline to Week 52]

      LIC was assessed using magnetic resonance imaging (MRI) mean liver proton transverse relaxation rates (R2).

    3. To Evaluate Change in Transfusion Requirements [Baseline to Week 52]

      Change in transfusion requirements from baseline.

    4. Absolute Change in Serum Erythropoietin [Baseline to Week 52]

      Absolute Change in Serum Erythropoietin from baseline.

    5. Absolute Change in Urinary Hepcidin [Baseline to Week 52]

      Absolute Change in Urinary Hepcidin from baseline

    6. Absolute Change in Transferrin Saturation [Baseline to Week 52]

      Transferrin Saturation was assessed using magnetic resonance imaging (MRI) mean liver proton transverse relaxation rates (R2)

    7. Labile Plasma Iron (LPI) [Baseline to Week 52]

      LPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The outcome was reported as LPI Unit, where, 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Male or female patients with low or intermediate (INT-1) risk MDS, determined via IPSS criteria, with transfusional iron overload. NOTE: Bone marrow morphology and cytogenetic studies completed within 3 months prior to screening can be used if the patient has been hematologically stable. Every attempt to obtain cytogenetics studies should be made; however, if there is culture failure, repeat marrow aspiration will not be mandated. In this case, RAEB with less than 11% marrow blasts will be accepted.

    • Patients on chelation therapy at the time of screening required a 1-day wash out prior to the first dose of study drug.

    • Age: greater than or equal to 18 years

    • Serum ferritin:

    • For entry into the screening period: serum ferritin greater than or equal to 1000 µg/mL on at least two occasions, at least two weeks apart, during the prior year. Samples must be obtained in the absence of concomitant infection;

    • For enrollment into the study: serum ferritin greater than or equal to 1000 µg/mL at screening (via the central lab) obtained in the absence of concomitant infection

    • A lifetime minimum of 20 previous packed red cell transfusions

    • Life expectancy greater than or equal to 6 months

    • Women must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy and/or oophorectomy, or tubal ligation or be postmenopausal (defined by amenorrhea for at least 12 months).

    • Able to provide written informed consent

    Exclusion Criteria:
    • Serum creatinine greater than 2 × upper limit of normal (ULN)

    • ALT or AST greater than 5 × ULN.

    • Clinical or laboratory evidence of active hepatitis B or hepatitis C (HBsAg in the absence of HBsAb -OR- HCV Ab positive with HCV RNA positive and ALT above the normal range)

    • Significant proteinuria as indicated by a urinary protein/creatinine ratio greater than 0.5 mg/mg in a non-first void urine sample during screening (or alternatively in two of three samples obtained for screening)

    • History of HIV positive test result (ELISA or Western blot)

    • ECOG performance status greater than 2

    • Uncontrolled systemic hypertension

    • Unstable cardiac disease not controlled by standard medical therapy

    • Third degree atrioventricular (AV) block or QT interval prolongation above the normal range

    • History of clinically relevant ocular toxicity related to iron chelation

    • Pregnancy or breast feeding

    • Treatment with a systemic investigational drug within the past 4 weeks or a topical investigational drug within the past 7 days.

    • Other surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of any drug. The investigator should be guided by evidence of any of the following:

    • inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding;

    • major gastrointestinal tract surgery, such as gastrectomy, gastroenterostomy, or bowel resection;

    • pancreatic injury or pancreatitis or indications of impaired pancreatic function/injury, as indicated by abnormal lipase or amylase;

    • urinary obstruction or difficulty in voiding.

    • History of non-compliance to medical regimens or patients who are considered potentially unreliable and/or not cooperative

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1Stanford University Medical CenterStanfordCaliforniaUnited States94305-5821
    2Karmanos Cancer CenterDetroitMichiganUnited States48201
    3MD Anderson Cancer CenterHoustonTexasUnited States77030-4009

    Sponsors and Collaborators

    • Novartis Pharmaceuticals

    Investigators

    • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00117507
    Other Study ID Numbers:
    • CICL670AUS02
    First Posted:
    Jul 7, 2005
    Last Update Posted:
    Jun 24, 2021
    Last Verified:
    Jun 1, 2021

    Study Results

    Participant Flow

    Recruitment DetailsThe study enrolled participants at 3 centers in United States.
    Pre-assignment DetailA total 24 participants were enrolled in the study of which 9 participants completed the study and 15 participants discontinued from the study.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD (Once Daily) per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    Period Title: Overall Study
    STARTED24
    COMPLETED9
    NOT COMPLETED15

    Baseline Characteristics

    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months.
    Overall Participants24
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    68.6
    (8.58)
    Sex: Female, Male (Count of Participants)
    Female
    8
    33.3%
    Male
    16
    66.7%

    Outcome Measures

    1. Primary Outcome
    TitleNumber of Participants With Adverse Events and Serious Adverse Events
    DescriptionAn adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. Any sign or symptom that occured from first dose of study treatment until end of study treatment.
    Time FrameUp To Week 52

    Outcome Measure Data

    Analysis Population Description
    The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months.
    Measure Participants24
    Adverse events
    24
    100%
    Serious adverse events
    11
    45.8%
    2. Secondary Outcome
    TitleAbsolute Change in Serum Ferritin From Baseline to Week 52
    DescriptionAbsolute change in serum ferritin after start of treatment with Deferasirox (ICL670).
    Time FrameBaseline to Week 52

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months.
    Measure Participants24
    Baseline
    3847.6
    (2854.54)
    Week 52/EOS (end of study)
    -729.8
    (2749.35)
    3. Secondary Outcome
    TitleAbsolute Change in Liver Iron Concentration (LIC) From Baseline to End of Study
    DescriptionLIC was assessed using magnetic resonance imaging (MRI) mean liver proton transverse relaxation rates (R2).
    Time FrameBaseline to Week 52

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population consisted of all patients who were registered in the study, whether or not they received treatment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    Measure Participants24
    Baseline
    20.64
    (9.747)
    Week 52/EOS
    -4.50
    (12.995)
    4. Secondary Outcome
    TitleTo Evaluate Change in Transfusion Requirements
    DescriptionChange in transfusion requirements from baseline.
    Time FrameBaseline to Week 52

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    Measure Participants24
    Number of Transfusions per Patient
    15.5
    (9.46)
    Number of Units of Blood Transfused per Patient
    34.0
    (24.65)
    5. Secondary Outcome
    TitleAbsolute Change in Serum Erythropoietin
    DescriptionAbsolute Change in Serum Erythropoietin from baseline.
    Time FrameBaseline to Week 52

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    Measure Participants24
    Baseline
    646.50
    Week 52/EOS
    -79.00
    6. Secondary Outcome
    TitleAbsolute Change in Urinary Hepcidin
    DescriptionAbsolute Change in Urinary Hepcidin from baseline
    Time FrameBaseline to Week 52

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    Measure Participants17
    Baseline
    327.63
    Week 52/EOS
    67.32
    7. Secondary Outcome
    TitleAbsolute Change in Transferrin Saturation
    DescriptionTransferrin Saturation was assessed using magnetic resonance imaging (MRI) mean liver proton transverse relaxation rates (R2)
    Time FrameBaseline to Week 52

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population consisted of all participants who were registered in the study, whether or not they received treatment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    Measure Participants24
    Baseline
    59.3
    (7.24)
    Week 52/EOS (Change from baseline)
    8.6
    (21.19)
    8. Secondary Outcome
    TitleLabile Plasma Iron (LPI)
    DescriptionLPI represents the component of non-transferrin bound iron and is an indicator of iron overload. The outcome was reported as LPI Unit, where, 1 LPI unit = the quantity of reactive oxygen species produced by approximately 1.5 μM Fe.
    Time FrameBaseline to Week 52

    Outcome Measure Data

    Analysis Population Description
    Intent-to-treat (ITT) population consisted of all patients who were registered in the study, whether or not they received treatment.
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    Measure Participants24
    Baseline
    0.70
    (0.638)
    Week 52/EOS
    0.22
    (0.460)

    Adverse Events

    Time FrameAdverse events were collected From Start of the Study up to EOS (Week 52). The safety set consisted of all participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.
    Adverse Event Reporting Description
    Arm/Group TitleDeferasirox
    Arm/Group DescriptionParticipants received deferasirox 20mg/kg/day OD per day for 12 months. Deferasirox was taken every morning 30 minutes before breakfast, if possible consistently around the same time between 7:00 and 9:00 AM. The tablets was dropped into water or orange juice and gently stirred for 1 to 3 minutes until completely dispersed.
    All Cause Mortality
    Deferasirox
    Affected / at Risk (%)# Events
    Total3/24 (12.5%)
    Serious Adverse Events
    Deferasirox
    Affected / at Risk (%)# Events
    Total11/24 (45.8%)
    Blood and lymphatic system disorders
    Splenic infarction1/24 (4.2%)
    Cardiac disorders
    Arrhythmia1/24 (4.2%)
    Cardiac failure congestive2/24 (8.3%)
    Left ventricular hypertrophy1/24 (4.2%)
    Gastrointestinal disorders
    Ascites1/24 (4.2%)
    Diarrhoea1/24 (4.2%)
    General disorders
    Asthenia1/24 (4.2%)
    Chest pain2/24 (8.3%)
    Chills1/24 (4.2%)
    Concomitant disease progression1/24 (4.2%)
    Oedema1/24 (4.2%)
    Oedema peripheral1/24 (4.2%)
    Pyrexia4/24 (16.7%)
    Hepatobiliary disorders
    Cholecystitis acute1/24 (4.2%)
    Infections and infestations
    Bronchitis1/24 (4.2%)
    Pneumonia1/24 (4.2%)
    Urinary tract infection2/24 (8.3%)
    Injury, poisoning and procedural complications
    Joint dislocation1/24 (4.2%)
    Skull fracture1/24 (4.2%)
    Subdural haemorrhage1/24 (4.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia1/24 (4.2%)
    Pain in extremity1/24 (4.2%)
    Neoplasms benign, malignant and unspecified (incl cysts and polyps)
    Acute myeloid leukaemia1/24 (4.2%)
    Nervous system disorders
    Depressed level of consciousness1/24 (4.2%)
    Syncope1/24 (4.2%)
    Renal and urinary disorders
    Nephrolithiasis1/24 (4.2%)
    Respiratory, thoracic and mediastinal disorders
    Dyspnoea2/24 (8.3%)
    Orthopnoea1/24 (4.2%)
    Pleural effusion1/24 (4.2%)
    Respiratory arrest1/24 (4.2%)
    Other (Not Including Serious) Adverse Events
    Deferasirox
    Affected / at Risk (%)# Events
    Total23/24 (95.8%)
    Blood and lymphatic system disorders
    Leukocytosis1/24 (4.2%)
    Monocytosis1/24 (4.2%)
    Splenic infarction1/24 (4.2%)
    Splenomegaly2/24 (8.3%)
    Thrombocytopenia1/24 (4.2%)
    Cardiac disorders
    Dilatation atrial1/24 (4.2%)
    Dilatation ventricular1/24 (4.2%)
    Palpitations2/24 (8.3%)
    Pericardial effusion1/24 (4.2%)
    Sinus tachycardia1/24 (4.2%)
    Tachycardia2/24 (8.3%)
    Ventricular tachycardia1/24 (4.2%)
    Ear and labyrinth disorders
    Vertigo1/24 (4.2%)
    Eye disorders
    Conjunctival discolouration1/24 (4.2%)
    Conjunctivitis1/24 (4.2%)
    Gastrointestinal disorders
    Abdominal distension2/24 (8.3%)
    Abdominal pain9/24 (37.5%)
    Abdominal pain upper3/24 (12.5%)
    Constipation4/24 (16.7%)
    Diarrhoea15/24 (62.5%)
    Flatulence1/24 (4.2%)
    Frequent bowel movements1/24 (4.2%)
    Gastrooesophageal reflux disease1/24 (4.2%)
    Haemorrhoidal haemorrhage1/24 (4.2%)
    Nausea11/24 (45.8%)
    Odynophagia1/24 (4.2%)
    Rectal haemorrhage1/24 (4.2%)
    Retching1/24 (4.2%)
    Stomach discomfort1/24 (4.2%)
    Vomiting4/24 (16.7%)
    General disorders
    Asthenia2/24 (8.3%)
    Chest pain1/24 (4.2%)
    Chills1/24 (4.2%)
    Concomitant disease progression1/24 (4.2%)
    Fatigue2/24 (8.3%)
    Feeling cold1/24 (4.2%)
    Malaise1/24 (4.2%)
    Oedema3/24 (12.5%)
    Oedema peripheral6/24 (25%)
    Pain1/24 (4.2%)
    Pyrexia3/24 (12.5%)
    Hepatobiliary disorders
    Hepatomegaly3/24 (12.5%)
    Jaundice1/24 (4.2%)
    Infections and infestations
    Bronchitis3/24 (12.5%)
    Catheter related infection1/24 (4.2%)
    Cellulitis1/24 (4.2%)
    Gastroenteritis viral1/24 (4.2%)
    Oral herpes1/24 (4.2%)
    Pneumonia1/24 (4.2%)
    Sinusitis1/24 (4.2%)
    Tooth infection1/24 (4.2%)
    Upper respiratory tract infection4/24 (16.7%)
    Urinary tract infection1/24 (4.2%)
    Injury, poisoning and procedural complications
    Contusion4/24 (16.7%)
    Excoriation1/24 (4.2%)
    Lower limb fracture1/24 (4.2%)
    Lumbar vertebral fracture1/24 (4.2%)
    Upper limb fracture1/24 (4.2%)
    Wound1/24 (4.2%)
    Investigations
    Alanine aminotransferase increased1/24 (4.2%)
    Aspartate aminotransferase increased1/24 (4.2%)
    Blood bilirubin increased1/24 (4.2%)
    Blood creatinine increased1/24 (4.2%)
    Breath sounds abnormal1/24 (4.2%)
    Haemoglobin decreased1/24 (4.2%)
    Heart rate irregular1/24 (4.2%)
    Lipase increased1/24 (4.2%)
    Weight decreased6/24 (25%)
    Weight increased1/24 (4.2%)
    Metabolism and nutrition disorders
    Anorexia2/24 (8.3%)
    Decreased appetite1/24 (4.2%)
    Dehydration1/24 (4.2%)
    Fluid retention1/24 (4.2%)
    Gout1/24 (4.2%)
    Hypercreatininaemia3/24 (12.5%)
    Hypokalaemia1/24 (4.2%)
    Hypomagnesaemia1/24 (4.2%)
    Musculoskeletal and connective tissue disorders
    Arthralgia1/24 (4.2%)
    Back pain2/24 (8.3%)
    Bone pain1/24 (4.2%)
    Groin pain1/24 (4.2%)
    Joint effusion1/24 (4.2%)
    Muscle atrophy1/24 (4.2%)
    Muscle spasms2/24 (8.3%)
    Osteoporosis1/24 (4.2%)
    Temporomandibular joint syndrome1/24 (4.2%)
    Nervous system disorders
    Headache3/24 (12.5%)
    Migraine1/24 (4.2%)
    Sciatica1/24 (4.2%)
    Syncope1/24 (4.2%)
    Vocal cord paralysis1/24 (4.2%)
    Psychiatric disorders
    Confusional state1/24 (4.2%)
    Depression2/24 (8.3%)
    Insomnia1/24 (4.2%)
    Restlessness1/24 (4.2%)
    Renal and urinary disorders
    Dysuria1/24 (4.2%)
    Incontinence1/24 (4.2%)
    Micturition urgency1/24 (4.2%)
    Pollakiuria2/24 (8.3%)
    Renal failure2/24 (8.3%)
    Respiratory, thoracic and mediastinal disorders
    Aspiration1/24 (4.2%)
    Cough5/24 (20.8%)
    Dysphonia2/24 (8.3%)
    Dyspnoea5/24 (20.8%)
    Dyspnoea exertional1/24 (4.2%)
    Epistaxis1/24 (4.2%)
    Lung infiltration1/24 (4.2%)
    Nasal congestion1/24 (4.2%)
    Pharyngolaryngeal pain1/24 (4.2%)
    Postnasal drip1/24 (4.2%)
    Rales3/24 (12.5%)
    Rhinorrhoea1/24 (4.2%)
    Sinus congestion1/24 (4.2%)
    Wheezing1/24 (4.2%)
    Skin and subcutaneous tissue disorders
    Dry skin2/24 (8.3%)
    Ecchymosis3/24 (12.5%)
    Hyperhidrosis1/24 (4.2%)
    Increased tendency to bruise1/24 (4.2%)
    Night sweats1/24 (4.2%)
    Periorbital oedema1/24 (4.2%)
    Petechiae1/24 (4.2%)
    Pruritus2/24 (8.3%)
    Purpura1/24 (4.2%)
    Rash4/24 (16.7%)
    Rash macular1/24 (4.2%)
    Skin exfoliation1/24 (4.2%)
    Skin lesion1/24 (4.2%)
    Vascular disorders
    Hypotension1/24 (4.2%)
    Pallor2/24 (8.3%)

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

    Results Point of Contact

    Name/TitleStudy Director
    OrganizationNovartis Pharmaceuticals
    Phone862-778-8300
    EmailNovartis.email@novartis.com
    Responsible Party:
    Novartis Pharmaceuticals
    ClinicalTrials.gov Identifier:
    NCT00117507
    Other Study ID Numbers:
    • CICL670AUS02
    First Posted:
    Jul 7, 2005
    Last Update Posted:
    Jun 24, 2021
    Last Verified:
    Jun 1, 2021