Cardiac T2* in Beta-thalassemia Patients on Deferasirox Treatment

Sponsor
Novartis (Industry)
Overall Status
Completed
CT.gov ID
NCT00447694
Collaborator
(none)
30
3
1
45
10
0.2

Study Details

Study Description

Brief Summary

The purpose of this trial is to evaluate changes in cardiac iron as measured by MRI T2* in beta-thalassemia patients with deferasirox treatment.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
An Open Label Trial Evaluating Cardiac T2* in Beta-thalassemia Patients on Deferasirox (ICL670) Treatment for 18 Months
Study Start Date :
Feb 1, 2006
Actual Primary Completion Date :
Nov 1, 2009
Actual Study Completion Date :
Nov 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: deferasirox every day for 77 weeks

Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.

Drug: Deferasirox
Oral deferasirox 30mg/kg/day once per day for 77 weeks.

Outcome Measures

Primary Outcome Measures

  1. Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2* [From Baseline to 25, 49, 77 Week]

    Cardiac T2* was measured in the short axis plane at the widest point of a 4-chamber localizer using custom breath-hold R2* gradient echo sequences modeled after techniques used by Anderson et al (2001) and Westwood et al (2003).

Secondary Outcome Measures

  1. Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks [From Baseline to 25, 49, 77 Week]

    MRI evaluation of liver iron concentration has been validated by liver biopsy (St Pierre et al 2005). Studies comparing T2* values of liver iron concentration (LIC) with LIC as assessed by biopsy have confirmed that T2* values reflect liver iron content (Wood et al 2003b). Direct tissue-validation of cardiac T2* measurements in humans has not been performed because endomyocardial biopsy is a dangerous and unreliable indicator of cardiac iron overload (Olson et al 1989, Fitchett et al 1980). However, it has been shown that cardiac T2* accurately reflects cardiac iron in a gerbil iron cardiomyopathy model (Wood et al 2004b). T2* measurements have shown excellent inter-scanner and inter-exam reproducibility, making them suitable for longitudinal monitoring (Westwood et al 2003a, Westwood et al 2003b).

  2. Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks [From Baseline to 25, 49, 77 Week]

    Magnetic resonance imaging (MRI)-measured cardiac T2* and cardiac function reflected by left and right ventricle ejection fraction. A standardized MRI protocol for T2* acquisition technique will be used in the centers. Images will be reviewed centrally by an expert MRI reader.

  3. Serum Ferritin and Changes From Baseline in Serum Ferritin During Study [From Baseline to 25, 49, 77 Week]

    Serum ferritin will be assessed at each study visit. Analysis was performed in Completer population consists of those participants who had a Week 77 MRI.

Eligibility Criteria

Criteria

Ages Eligible for Study:
10 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Male or female β-thalassemia outpatients on chronic transfusion therapy (defined as > 8 transfusions per year)

  • Lifetime minimum of 100 previous packed red blood cell transfusions

  • Patients currently on chelation therapy will require a one day wash out prior to the first dose of study drug

  • Age ≥ 10 years

  • Sexually active females of childbearing potential must have a negative serum or urine pregnancy test and use an effective method of contraception, or must have undergone clinically documented total hysterectomy.

Exclusion Criteria:
  • Ejection Fraction < 56 % measured using steady-state free precession imaging by MRI

  • Contraindication to MRI, including cardiac pacemaker, brain aneurysm clip, implanted neurostimulator, insulin pump, cochlear implant, metal slivers in the eyes, intrauterine device or any other MRI incompatible metal implants or intractable claustrophobia

  • Abnormal laboratory values as defined by the protocol

  • Clinical or laboratory evidence of active Hepatitis B or Hepatitis C

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

  • Uncontrolled systemic hypertension

  • Second or third degree A-V block

  • Life-threatening arrhythmias, including sustained ventricular tachycardia and aborted sudden death, within the last year

  • History of cardiac conditions or unstable cardiac disease not controlled by standard medical therapy

  • History of clinically relevant ocular toxicity related to iron chelation

  • Systemic diseases (cardiovascular, renal, hepatic, etc.) which would prevent study treatment

  • Pregnancy or breast feeding (documented negative pregnancy test required for study entry)

  • Patients enrolled in an ongoing clinical trial of deferasirox (ICL670) cannot be withdrawn in order to participate in this study

  • Treatment with systemic investigational drug within the past 4 weeks or 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

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

  • Other inclusion/exclusion criteria may apply

Contacts and Locations

Locations

Site City State Country Postal Code
1 Childrens Hospital of Los Angeles Los Angeles California United States 90027
2 Children's Hospital and Research Center at Oakland Oakland California United States 94609
3 Children's Memorial Hospital Chicago Illinois United States 60614

Sponsors and Collaborators

  • Novartis

Investigators

  • Principal Investigator: Thomas Coates, MD, Childresn's Hospital of Los Angeles
  • Principal Investigator: Alexis Thompson, MD, Children's Memorial Hospital of Chicago
  • Principal Investigator: Paul Harmatz, MD, Children's Hospital and Research Center at Oakland

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00447694
Other Study ID Numbers:
  • CICL670AUS04
First Posted:
Mar 15, 2007
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021

Study Results

Participant Flow

Recruitment Details The study was conducted at 4 centers in the United States
Pre-assignment Detail A total number of participants planned for this study was 30. The total number of 28 participants enrolled in the study, of these 22 completed the study and 6 discontinued the study.
Arm/Group Title Deferasirox
Arm/Group Description Participants received Deferasirox 30 milligrams per kilogram per day (mg/kg/day) orally once daily (OD), 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 gram (g), tablets were dissolved in at least 100 milliliter (mL) of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Period Title: Overall Study
STARTED 28
COMPLETED 22
NOT COMPLETED 6

Baseline Characteristics

Arm/Group Title Deferasirox
Arm/Group Description Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Overall Participants 28
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
22.6
(8.67)
Sex: Female, Male (Count of Participants)
Female
20
71.4%
Male
8
28.6%
Race/Ethnicity, Customized (participants) [Number]
Caucasian
9
32.1%
Black
0
0%
Oriental
7
25%
Other
12
42.9%

Outcome Measures

1. Primary Outcome
Title Magnetic Resonance Imaging (MRI) T2* and Absolute Change From Baseline in MRI T2*
Description Cardiac T2* was measured in the short axis plane at the widest point of a 4-chamber localizer using custom breath-hold R2* gradient echo sequences modeled after techniques used by Anderson et al (2001) and Westwood et al (2003).
Time Frame From Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population (CP) consists of those participants who had a Week 77 MRI.
Arm/Group Title Deferasirox
Arm/Group Description Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants 22
Baseline
9.92
(3.922)
Week 25
11.73
(6.091)
Week 25 Absolute Change from Baseline
1.77
(3.203)
Week 49
11.93
(6.489)
Week 49 Absolute Change from Baseline
2.01
(3.792)
Week 77
12.10
(6.461)
Week 77 Absolute Change from Baseline
2.18
(3.927)
2. Secondary Outcome
Title Change From Baseline in Liver Iron Concentration (LIC) Was Measured by MRI R2 From Absolute Change From Baseline to 101 Weeks
Description MRI evaluation of liver iron concentration has been validated by liver biopsy (St Pierre et al 2005). Studies comparing T2* values of liver iron concentration (LIC) with LIC as assessed by biopsy have confirmed that T2* values reflect liver iron content (Wood et al 2003b). Direct tissue-validation of cardiac T2* measurements in humans has not been performed because endomyocardial biopsy is a dangerous and unreliable indicator of cardiac iron overload (Olson et al 1989, Fitchett et al 1980). However, it has been shown that cardiac T2* accurately reflects cardiac iron in a gerbil iron cardiomyopathy model (Wood et al 2004b). T2* measurements have shown excellent inter-scanner and inter-exam reproducibility, making them suitable for longitudinal monitoring (Westwood et al 2003a, Westwood et al 2003b).
Time Frame From Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population consists of those participants who had a Week 77 MRI.
Arm/Group Title Deferasirox
Arm/Group Description Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants 22
Baseline
19.85
(3.309)
Week 25
17.23
(15.393)
Week 25 Absolute Change from Baseline
-2.89
(4.169)
Week 49
17.0
(17.548)
Week 49 Absolute Change from Baseline
-2.85
(4.883)
Week 77
16.62
(20.114)
Week 77 Absolute Change from Baseline
-3.23
(7.708)
3. Secondary Outcome
Title Left Ventricular Ejection Fraction (LVEF) and Change in Left Ventricular Ejection Fraction From Baseline to 101 Weeks
Description Magnetic resonance imaging (MRI)-measured cardiac T2* and cardiac function reflected by left and right ventricle ejection fraction. A standardized MRI protocol for T2* acquisition technique will be used in the centers. Images will be reviewed centrally by an expert MRI reader.
Time Frame From Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population consisting of those participants who had a Week 77 MRI.
Arm/Group Title Deferasirox
Arm/Group Description Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants 22
Baseline
64.01
(6.751) 228.6%
Week 25
62.17
(6.352) 222%
Week 25 Absolute change from baseline
-1.84
(7.306) -6.6%
Week 49
61.61
(13.726) 220%
Week 49 Absolute change from baseline
-2.68
(14.546) -9.6%
Week 77
63.84
(6.112) 228%
Week 77 Absolute change from baseline
0.11
(7.299) 0.4%
4. Secondary Outcome
Title Serum Ferritin and Changes From Baseline in Serum Ferritin During Study
Description Serum ferritin will be assessed at each study visit. Analysis was performed in Completer population consists of those participants who had a Week 77 MRI.
Time Frame From Baseline to 25, 49, 77 Week

Outcome Measure Data

Analysis Population Description
The analysis was performed in Completer population consists of those participants who had a Week 77 MRI.
Arm/Group Title Deferasirox
Arm/Group Description Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
Measure Participants 22
Baseline
4343.75
(3486.525)
Week 25
4280.77
(5261.563)
Week 25 Absolute change from baseline
-62.98
(2294.635)
Week 49
3759.29
(3966.107)
Week 49 Absolute change from baseline
-593.36
(1534.040)
Week 77
3179.81
(3439.357)
Week 77 Absolute change from baseline
-882.74
(1368.202)

Adverse Events

Time Frame Adverse events are collected from First Patient First Visit (FPFV) until Last Patient Last Visit (LPLV). All adverse events reported in this record are from date of First Patient First Treatment until Last Patient Last Visit (LPLV) up to week 77.
Adverse Event Reporting Description The analysis was performed on safety set population defined as all participants who received study drug and had at least one post-baseline safety assessment.
Arm/Group Title All Patients
Arm/Group Description Participants received Deferasirox 30 mg/kg/day orally OD, 30 minutes before breakfast, preferably around the same time every morning if possible. Deferasirox tablets were dropped into water or orange juice, or apple juice and stirred until completely dispersed. For doses less than 1 g, tablets were dissolved in at least 100 mL of liquid; for doses of 1 to 3 g, tablets were dissolved in at least 200 mL. After tablets were fully disintegrated, the liquid was promptly consumed.
All Cause Mortality
All Patients
Affected / at Risk (%) # Events
Total 0/27 (0%)
Serious Adverse Events
All Patients
Affected / at Risk (%) # Events
Total 8/27 (29.6%)
Blood and lymphatic system disorders
Disseminated intravascular coagulation 1/27 (3.7%)
Thrombocytopenia 1/27 (3.7%)
Cardiac disorders
Arrhythmia 1/27 (3.7%)
Cardiac failure 1/27 (3.7%)
Tachycardia 1/27 (3.7%)
Congenital, familial and genetic disorders
Fanconi syndrome 1/27 (3.7%)
Gastrointestinal disorders
Abdominal compartment syndrome 1/27 (3.7%)
Abdominal pain 4/27 (14.8%)
Ascites 1/27 (3.7%)
Colitis 1/27 (3.7%)
Gastrointestinal oedema 1/27 (3.7%)
Nausea 1/27 (3.7%)
Pancreatitis 1/27 (3.7%)
Vomiting 3/27 (11.1%)
General disorders
Multi-organ failure 1/27 (3.7%)
Pyrexia 5/27 (18.5%)
Hepatobiliary disorders
Hepatic failure 1/27 (3.7%)
Hepatic steatosis 1/27 (3.7%)
Hepatitis 1/27 (3.7%)
Infections and infestations
Aspergillosis 1/27 (3.7%)
Bacterial infection 1/27 (3.7%)
Bronchitis viral 1/27 (3.7%)
Herpes simplex 1/27 (3.7%)
Pneumonia 1/27 (3.7%)
Sepsis 1/27 (3.7%)
Septic shock 1/27 (3.7%)
Urinary tract infection 1/27 (3.7%)
Urinary tract infection fungal 1/27 (3.7%)
Injury, poisoning and procedural complications
Fibula fracture 1/27 (3.7%)
Splenic rupture 1/27 (3.7%)
Tibia fracture 1/27 (3.7%)
Investigations
Blood creatinine increased 1/27 (3.7%)
Blood phosphorus decreased 1/27 (3.7%)
Ejection fraction decreased 1/27 (3.7%)
Urine analysis abnormal 1/27 (3.7%)
Metabolism and nutrition disorders
Acidosis 1/27 (3.7%)
Acidosis hyperchloraemic 1/27 (3.7%)
Anorexia 1/27 (3.7%)
Dehydration 2/27 (7.4%)
Hyperglycaemia 1/27 (3.7%)
Musculoskeletal and connective tissue disorders
Back pain 1/27 (3.7%)
Nervous system disorders
Depressed level of consciousness 1/27 (3.7%)
Unresponsive to stimuli 1/27 (3.7%)
Psychiatric disorders
Mental status changes 1/27 (3.7%)
Psychotic disorder 1/27 (3.7%)
Renal and urinary disorders
Azotaemia 1/27 (3.7%)
Polyuria 1/27 (3.7%)
Renal failure 1/27 (3.7%)
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain 1/27 (3.7%)
Pulmonary oedema 1/27 (3.7%)
Respiratory failure 1/27 (3.7%)
Vascular disorders
Hypoperfusion 1/27 (3.7%)
Hypotension 2/27 (7.4%)
Shock 1/27 (3.7%)
Other (Not Including Serious) Adverse Events
All Patients
Affected / at Risk (%) # Events
Total 27/27 (100%)
Cardiac disorders
Left atrial dilatation 1/27 (3.7%)
Left ventricular hypertrophy 2/27 (7.4%)
Sinus bradycardia 1/27 (3.7%)
Sinus tachycardia 1/27 (3.7%)
Tachycardia 2/27 (7.4%)
Ear and labyrinth disorders
Vertigo 1/27 (3.7%)
Eye disorders
Conjunctivitis 1/27 (3.7%)
Conjunctivitis allergic 1/27 (3.7%)
Dry eye 1/27 (3.7%)
Eye irritation 1/27 (3.7%)
Gastrointestinal disorders
Abdominal pain 7/27 (25.9%)
Abdominal pain lower 1/27 (3.7%)
Constipation 2/27 (7.4%)
Diarrhoea 12/27 (44.4%)
Dyspepsia 1/27 (3.7%)
Gastritis 1/27 (3.7%)
Nausea 16/27 (59.3%)
Vomiting 6/27 (22.2%)
General disorders
Chest discomfort 3/27 (11.1%)
Chills 2/27 (7.4%)
Fatigue 9/27 (33.3%)
Non-cardiac chest pain 1/27 (3.7%)
Oedema 1/27 (3.7%)
Oedema peripheral 1/27 (3.7%)
Pain 2/27 (7.4%)
Pyrexia 10/27 (37%)
Hepatobiliary disorders
Cholelithiasis 1/27 (3.7%)
Immune system disorders
House dust allergy 1/27 (3.7%)
Infections and infestations
Candidiasis 1/27 (3.7%)
Ear infection 1/27 (3.7%)
Folliculitis 1/27 (3.7%)
Fungal infection 1/27 (3.7%)
Hordeolum 1/27 (3.7%)
Nasopharyngitis 11/27 (40.7%)
Oral herpes 1/27 (3.7%)
Pharyngitis 1/27 (3.7%)
Sinusitis 3/27 (11.1%)
Upper respiratory tract infection 4/27 (14.8%)
Urinary tract infection 2/27 (7.4%)
Vulvovaginal mycotic infection 2/27 (7.4%)
Injury, poisoning and procedural complications
Animal bite 1/27 (3.7%)
Arthropod bite 1/27 (3.7%)
Arthropod sting 1/27 (3.7%)
Clavicle fracture 1/27 (3.7%)
Contusion 1/27 (3.7%)
Excoriation 2/27 (7.4%)
Joint injury 1/27 (3.7%)
Thoracic vertebral fracture 1/27 (3.7%)
Wrist fracture 1/27 (3.7%)
Investigations
Alanine aminotransferase increased 2/27 (7.4%)
Aspartate aminotransferase increased 2/27 (7.4%)
Blood 1,25-dihydroxycholecalciferol decreased 1/27 (3.7%)
Blood creatinine increased 2/27 (7.4%)
Ejection fraction decreased 1/27 (3.7%)
Electrocardiogram ST-T change 2/27 (7.4%)
Hepatic enzyme increased 1/27 (3.7%)
Transaminases increased 1/27 (3.7%)
Urine albumin/creatinine ratio abnormal 1/27 (3.7%)
Urine albumin/creatinine ratio increased 1/27 (3.7%)
Urine output decreased 2/27 (7.4%)
Weight decreased 1/27 (3.7%)
Metabolism and nutrition disorders
Alkalosis 1/27 (3.7%)
Anorexia 1/27 (3.7%)
Carnitine deficiency 2/27 (7.4%)
Copper deficiency 1/27 (3.7%)
Decreased appetite 1/27 (3.7%)
Dehydration 1/27 (3.7%)
Hyperglycaemia 2/27 (7.4%)
Hyperkalaemia 1/27 (3.7%)
Hypocalcaemia 1/27 (3.7%)
Hypoglycaemia 1/27 (3.7%)
Hypokalaemia 1/27 (3.7%)
Selenium deficiency 1/27 (3.7%)
Vitamin A deficiency 1/27 (3.7%)
Vitamin B complex deficiency 3/27 (11.1%)
Vitamin B1 deficiency 1/27 (3.7%)
Vitamin B12 deficiency 1/27 (3.7%)
Vitamin B6 deficiency 1/27 (3.7%)
Vitamin C deficiency 1/27 (3.7%)
Vitamin D deficiency 5/27 (18.5%)
Vitamin E deficiency 1/27 (3.7%)
Zinc deficiency 2/27 (7.4%)
Musculoskeletal and connective tissue disorders
Arthralgia 6/27 (22.2%)
Back pain 3/27 (11.1%)
Bone pain 1/27 (3.7%)
Extremity contracture 1/27 (3.7%)
Flank pain 1/27 (3.7%)
Joint range of motion decreased 1/27 (3.7%)
Myalgia 2/27 (7.4%)
Neck pain 1/27 (3.7%)
Osteopenia 1/27 (3.7%)
Pain in extremity 3/27 (11.1%)
Nervous system disorders
Basal ganglion degeneration 1/27 (3.7%)
Dizziness 5/27 (18.5%)
Headache 9/27 (33.3%)
Hypoaesthesia 1/27 (3.7%)
Paraesthesia 1/27 (3.7%)
Psychiatric disorders
Insomnia 1/27 (3.7%)
Renal and urinary disorders
Chromaturia 1/27 (3.7%)
Dysuria 1/27 (3.7%)
Reproductive system and breast disorders
Dysmenorrhoea 1/27 (3.7%)
Respiratory, thoracic and mediastinal disorders
Asthma 1/27 (3.7%)
Cough 10/27 (37%)
Dyspnoea 1/27 (3.7%)
Nasal congestion 4/27 (14.8%)
Pharyngolaryngeal pain 3/27 (11.1%)
Postnasal drip 1/27 (3.7%)
Respiratory tract congestion 1/27 (3.7%)
Wheezing 1/27 (3.7%)
Skin and subcutaneous tissue disorders
Dermatitis contact 1/27 (3.7%)
Ingrown hair 1/27 (3.7%)
Rash 7/27 (25.9%)
Skin irritation 1/27 (3.7%)
Urticaria 3/27 (11.1%)
Surgical and medical procedures
Wisdom teeth removal 1/27 (3.7%)
Vascular disorders
Hypertension 1/27 (3.7%)
Hypotension 2/27 (7.4%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There IS 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/Title Study Director
Organization Novartis Pharmaceuticals
Phone 862-778-8300
Email Novartis.email@novartis.com
Responsible Party:
Novartis
ClinicalTrials.gov Identifier:
NCT00447694
Other Study ID Numbers:
  • CICL670AUS04
First Posted:
Mar 15, 2007
Last Update Posted:
Jun 14, 2021
Last Verified:
Jun 1, 2021