Pulmonary Disease, Chronic ObstructivePhase 3NCT01192191
A Long-term Safety Study of Fluticasone Furoate (FF)/GW642444 in Japanese Subjects With COPD
A Phase 3 study testing Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg and Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 35 sites in Japan.
Trial summary
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg and Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 35 sitesJapan
- Study dates
- Aug 2010to Jan 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Out patient at least 40 years of age
- Both genders; females childbearing potencial must be willing to use birth control method
- A diagnosis of COPD at Screening
- Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
- Post-bronchodilator FEV1/FVC ratio of less than 70%
- Post-bronchodilator FEV1 of less than 80%
Who cannot join
- Current diagnosis of sthma
- Respiratory disorders other than COPD
- Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
- Concurrent other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, medications related to study drugs
- Taking another investigational medication or medication prohibited for use during this study
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
Japan35 sites
GSK Investigational Site
Fukuoka, 811-2201
GSK Investigational Site
Fukuoka, 819-8555
GSK Investigational Site
Fukushima, 964-0871
GSK Investigational Site
Gunma, 371-0048
GSK Investigational Site
Hiroshima, 732-0057
GSK Investigational Site
Hokkaido, 001-0901
GSK Investigational Site
Hokkaido, 064-0915
GSK Investigational Site
Hokkaido, 070-8644
GSK Investigational Site
Hyōgo, 651-0073
GSK Investigational Site
Ibaraki, 300-0053
GSK Investigational Site
Ibaraki, 310-0015
GSK Investigational Site
Ishikawa, 920-8610
GSK Investigational Site
Kagawa, 760-0073
GSK Investigational Site
Kagawa, 763-8502
GSK Investigational Site
Kanagawa, 239-0821
GSK Investigational Site
Kyoto, 601-1495
GSK Investigational Site
Kyoto, 615-8087
GSK Investigational Site
Miyagi, 981-8563
GSK Investigational Site
Miyagi, 984-8560
GSK Investigational Site
Nagano, 390-0303
GSK Investigational Site
Nagano, 390-0832
GSK Investigational Site
Nagano, 390-8601
GSK Investigational Site
Nagano, 391-0011
GSK Investigational Site
Ōita, 870-0921
GSK Investigational Site
Ōita, 876-0047
GSK Investigational Site
Okayama, 701-0304
GSK Investigational Site
Osaka, 530-0012
GSK Investigational Site
Osaka, 545-8586
GSK Investigational Site
Osaka, 576-0016
GSK Investigational Site
Osaka, 589-0022
GSK Investigational Site
Tokyo, 185-0014
GSK Investigational Site
Tokyo, 187-0024
GSK Investigational Site
Toyama, 930-0194
GSK Investigational Site
Wakayama, 641-8510
GSK Investigational Site
Yamanashi, 400-0031
About this study
Official title: A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg, Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg
- Keywords
- GW642444, COPD, Fluticasone Furoate
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcgDrug
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcgDrug
Fluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| Fluticasone Furoate/GW642444 100/25mcg | Experimental | Combination inhaled corticosteroid and long-acting beta2-agonist Receives: Drug: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg |
| Fluticasone Furoate/GW642444 200/25mcg | Experimental | Combination inhaled corticosteroid and long-acting beta2-agonist Receives: Drug: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.
Measured: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.
Measured: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Secondary outcomes (8)
Number of Participants With Pneumonia During the Treatment Period
Pneumonia is an inflammatory condition of the lung, affecting primarily the microscopic air sacs known as alveoli. All diagnoses of pneumonia (radiographically confirmed or unconfirmed) were reported as an AE or SAE. An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the ot
Measured: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Hematological parameters included: Basophils (Baso), Eosinophils (Eosin), Lymphocytes (Lymph), Monocytes (Mono), Total Neutrophils (TN), Hemoglobin (Hemo), Hematocrit (Hmcrt), Platelet Count (PT), Red Blood Cell Count (RBC Count), White Blood Cell Count (WBC Count). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.
Measured: Baseline (Week -2), and Week 52/Withdrawal (WD)
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Clinical chemistry and urinalysis parameters included: Albumin, Alkaline Phosphatase (AP), Alanine Amino Transferase (ALT), Aspartate Amino Transferase (AST), Bilirubin (Direct [BD], Indirect [BI], and Total [BT]), Creatine Kinase (CK), Chloride, Carbon Dioxide content/Bicarbonate (CO2/BC), Creatinine, Gamma Glutamyl Transferase (GGT), Glucose, Potassium, Lactate Dehydrogenase (LDH), Sodium, Urine pH, Urine Specific Gravity (USG),Total Protein (TP), Urea/Blood urea nitrogen (BUN), and Uric Acid (UA). Data are reported as the number of participants who had low, normal, and high levels at BL (Week-2) and Week 52/WD.
Measured: Baseline (Week -2), and Week 52/Withdrawal (WD
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
Urinalysis parameters included: Urine Occult Blood (UOB), Urine Glucose (UG), Urine Ketones (UK), Urine Protein (UP), and Urine Leukocyte Esterase test for detecting White Blood Cell (UWBC). The dipstick was a strip used to detect the presence or absence of these parameters in the urine sample. The dipstick test gives results in a semi-quantitative manner, and results can be read as negative (Neg), Trace, 1+, 2+, and 3+, indicating proportional concentrations in the urine sample. Data are reported as the number of participants who had neg, trace, 1+, 2+, and 3+ levels at Baseline (Week -2) and Week 52/WD.
Measured: Baseline (Week -2), Week 52/Withdrawal (WD)
Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)
24-hour urinary cortisol excretion was calculated by multiplying the total volume of urine by the concentration of urinary cortisol. Cortisol is a hormone released from the adrenal gland that helps in fat, protein, and carbohydrate metabolism. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Blood pressure measurement included systolic blood pressure (SBP) and diastolic blood pressure (DBP) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD. Blood pressure was measured in a sitting position after a participant was kept at rest for at least 5 minutes. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Heart rate was measured in a sitting position after a participant was kept at rest for at least 5 minutes at assessment time points (Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Measured: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
A 12-lead ECG was recorded in a supine position after the participant was kept at rest in this position for at least 5 minutes at assessment time points (Week 12, Week 24, and Week52). Data are presented for clinically significant (CS) as well as not clinically significant (NCS) abnormal findings. Any abnormal ECG, including those that worsen from baseline, and clinically significant as assessed by the investigator were recorded as CS.
Measured: Baseline (Week -2), Week 12, Week 24, and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01192191
- Sponsor's protocol ID
- 114156
- Status last verified
- Nov 2016
- First submitted
- 30 Aug 2010
- Last updated
- 11 Jan 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Long-term Study to Evaluate the Safety and Tolerability of Fluticasone Furoate (FF)/GW642444 Inhalation Powder in Japanese Subjects With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT01192191
- Acronym / sponsor ID
- 114156
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Keywords
- GW642444, COPD, Fluticasone Furoate
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 31 Aug 2010 (estimated)
- Results
- Posted 12 Aug 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of the study is to evaluate the safety and tolerability of fluticasone furoate/GW642444 inhalation powder when administered once-daily for 52 weeks in Japanese patients with COPD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluticasone Furoate/GW642444 100/25mcg | Experimental | Drug: Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcgCombination inhaled corticosteroid and long-acting beta2-agonist |
| Fluticasone Furoate/GW642444 200/25mcg | Experimental | Drug: Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcgCombination inhaled corticosteroid and long-acting beta2-agonist |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Out patient at least 40 years of age
- Both genders; females childbearing potencial must be willing to use birth control method
- A diagnosis of COPD at Screening
- Subjects with a current or prior history of at least 10 pack-years of cigarett smoking at Screening
- Post-bronchodilator FEV1/FVC ratio of less than 70%
Key exclusion criteria (6 listed)
- Current diagnosis of sthma
- Respiratory disorders other than COPD
- Upper or lower respiratory infection, or exacerbation of COPD within 4 weeka prior to Screening
- Concurrent other disease that would confound study participation or affect subject safety
- Allergies to study drugs, study drugs' excipients, medications related to study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcgFluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks | Drug | Fluticasone Furoate/GW642444 100/25mcg |
| Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcgFluticasone furoate/GW642444 inhalation powder inhaled orally once daily for 52 weeks | Drug | Fluticasone Furoate/GW642444 200/25mcg |
Primary outcome
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period
Time frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs (occurring at a frequency threshold >=5%) and SAEs.
Number of Participants With Any Drug-related AE and Any Drug-related SAE Throughout the Treatment Period
Time frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or require medical or surgical intervention to prevent one of the other outcomes listed in the definition above, or is an event of possible drug-induced liver injury. Relatedness was assessed by the investigator.
8 secondary outcomes
Number of Participants With Pneumonia During the Treatment Period
Time frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])
Number of Participants for the Indicated Hematological Parameters Who Experienced Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Time frame: Baseline (Week -2), and Week 52/Withdrawal (WD)
Number of Participants for the Indicated Clinical Chemistry and Urinalysis Parameters Who Experienced a Low, Normal, and High Levels at Baseline (BL) and Week 52/Withdrawal (WD)
Time frame: Baseline (Week -2), and Week 52/Withdrawal (WD
Number of Participants for the Indicated Urinalysis Parameters Tested by Dipstick at Baseline (BL) and Week 52/Withdrawal (WD)
Time frame: Baseline (Week -2), Week 52/Withdrawal (WD)
Change From Baseline in 24-hour Urinary Cortisol Excretion at Weeks 24 and 52/Withdrawal (WD)
Time frame: Baseline (Week 0), Week 24, and Week 52/Withdrawal (WD)
Change From Baseline in Blood Pressure at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, and Week 52/WD
Change From Baseline in Heart Rate (HR) at Weeks 4, 8, 12, 16, 24, 32, 40, and 52; Week 24/WD; and Week 52/WD
Time frame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 16, Week 24, Week 32, Week 40, Week 52, Week 24/WD, Week 52/WD
Number of Participants With Abnormal 12-lead Electrocardiogram (ECG) Findings
Time frame: Baseline (Week -2), Week 12, Week 24, and Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fluticasone Furoate/GW642444 Inhalation Powder 100/25mcg and Fluticasone Furoate/GW642444 Inhalation Powder 200/25mcg in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 35 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Aug 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Any Non-serious Adverse Event (AE) and Any Serious Adverse Event (SAE) Throughout the Treatment Period (time frame: From the start of investigational product to the last dose of treatment (up to Week 52/Withdrawal [WD])). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2017.