Renal DiseasePhase 1NCT01468259
A Multi-Center, Open-Label Study
A Phase 1 study testing Droxidopa in people with Renal Disease and End Stage Renal Disease, run by Chelsea Therapeutics at 1 site in United States.
Trial summary
This study will be an open-label, single-treatment, single-dose, parallel group study to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and End Stage Renal Disease (ESRD) after a single dose compared to matched healthy subjects with normal renal function. Read more about this study
- Who is it for?
- Ages 18 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Disease, End Stage Renal Disease
- What is being tested?
- Droxidopa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Dec 2012
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Informed Consent
- Male or Female between 18 and 79 years
- Female subject of childbearing potential not surgically sterile or min 2 years postmenopausal must use approved contraceptives
- BMI 20 to 40 kg per m2
- Refrain from exercise
- eGFR per protocol for condition
Show all 10Show fewer
- Sufficient venous access
- Stable medication dosing 14 days prior to and during study
- Healthy control subjects must show good general health per protocol
- Subjects will be matched Healthy to Renal Impaired by demographics data
Who cannot join
- Inability to complete study
- Insufficient venous access
- Clinically significant illness within 4 weeks of study
- History of clinically unstable disease except renal impairment in those subjects
- Medical or surgical conditions that may inhibit absorption of IP
- Laboratory value or medical issue which may interfere with study data or be hazardous for the subject
Show all 27Show fewer
- Medication that may interfere with drug absorption or elimination process 4 weeks prior to study
- Consumption of grapefruit products within 7 days prior and after study
- Dose changes of medications 14 days prior to and during study
- Active alcohol abuse or drug addiction
- Positive alcohol test at screening or after
- Excessive xanthine consumption
- Positive serology test Hepatitis B or Hepatitis C or HIV
- Excessive nicotine usage
- Positive urine screen for drugs of abuse without prescription
- Clinically relevant abnormal 12 lead ECG
- Donation of bood or plasma or platelets within 30 days of study
- Clinical trial with another agent within 30 days or 5 half lives whichever is longer
- Informed consent unavailable or withdrawn
- Any condition the investigator feels would interfere with study data or subjects health
- Employee or relative of study center or center staff or investigator
- Any condition that may increase risk for subject
- Clinically significant lab value
- Clinically significant acute or chronic disease other than renal impairment in those subjects that may interfere with data or health
- Medication dose change within 14 days of study
- Seated BP greater than 180 over 105
- Healthy subject with history of renal impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Multi-Center, Open-Label Study to Examine the Pharmacokinetics of a Single Dose of Droxidopa in Subjects With Renal Impairment Compared to Healthy Volunteers
This study will be an open-label, single-treatment, single-dose, parallel group study to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and End Stage Renal Disease (ESRD) after a single dose compared to matched healthy subjects with normal renal function.
A total of 48 male or female subjects, 16 subjects with normal renal function (eGFR greater than 90 mL/min/1.73m²) and eight each (8) with mild (60 less than eGFR less than 89 mL/min/1.73m²), moderate (30 less than eGFR less than 59 mL/min/1.73m²), or severe (15 less than eGFR less than 29 mL/min/1.73m²) renal impairment or ESRD (eGFR < 15 mL/min/1.73m² and requiring hemodialysis) will be selected according to the inclusion and exclusion criteria. The medical and laboratory examinations will take place within 28 days before dosing. A single dose of 600 mg of droxidopa as an investigational drug will be administered with 240 mL of water after an overnight fast (minimum 10 hours).
Read more
Blood samples for the measurement of plasma concentrations of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours after dosing for healthy volunteers and subjects with mild, moderate, and severe renal impairment and those with ESRD. For the latter, samples will be collected on both a non-hemodialysis and a hemodialysis visit.
During dialysis, samples of dialysate, from the arterial and venous sides of the dialyzer will be collected at 30-minute intervals during the dialysis period. In addition, the entire dialysate will be collected, its volume recorded, and a sample retained for the measurement of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid concentrations.
Urine samples for the measurement of urinary excretion of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected before and over the following intervals after dosing: 0 2, 2-4, 4-6, 6-8, 8-12, 12-24, and 24-36 hours for healthy volunteers and subjects with mild, moderate, and severe renal impairment.
A post-study visit with physical examination and laboratory tests will take place within seven (7) days after the last PK blood sampling.
Read the detailed description
Introduction Droxidopa (L-DOPS) is an orally administered, synthetic catecholamine that is converted to the sympathetic neurotransmitter norepinephrine (NE) through a single step of decarboxylation by the endogenous enzyme 3,4-dihydroxyphenylalanine (DOPA) decarboxylase. Droxidopa was originally developed by Sumitomo Pharmaceuticals Co. Ltd., and has been marketed in Japan since 1989 for the indications listed below.
- Improvement of frozen gait and dizziness on standing up in patients with Parkinson's Disease.
- Improvement of orthostatic hypotension, syncope, and dizziness on standing up in patients with Shy-Drager syndrome and familial amyloid polyneuropathy.
- Improvement of the following symptoms of orthostatic hypotension in patients undergoing hemodialysis: dizziness, light-headed feeling, dizziness on standing up, malaise, and weakness.
Chelsea hypothesizes that these indications have an deficiency or lack of activity of the adrenergic neurotransmitter NE which can be affected by the use of a NE prodrug.
In Phase 1 clinical studies conducted in Japanese and Caucasian subjects, droxidopa was well tolerated and no differences were noted in oral absorption between the two groups. Apart from a moderate increase in heart rate in one Caucasian subject (receiving 600 mg droxidopa), which was considered to be possibly related to study medication, there were no other adverse events (AEs) that were considered to be related to droxidopa treatment. The maximum plasma concentration (Cmax) was reached between 2 and 3 hours after single, oral doses of droxidopa (100 to 900 mg). The plasma elimination half-life (t½) of droxidopa was 1.4 - 1.5 hours and approximately 15% of the drug was recovered unchanged in the urine. No drug accumulation was observed after multiple oral dosing with droxidopa (300 mg twice daily for 5 days).
Although the therapeutic effects of droxidopa are believed to be due to the conversion of droxidopa to NE, the major metabolite of droxidopa is methylated droxidopa (3-OM-DOPS).
After administration of single 100 mg and 300 mg doses to healthy volunteers, droxidopa, 3-OM-DOPS, and NE were observed in the urine. The 24-hour excretions of droxidopa and 3-OM-DOPS accounted for approximately 15% and 8% of the administered dose (3-OM-DOPS uncorrected for molecular weight), suggesting that renal function may impact the clearance of droxidopa and 3-OM-DOPS.1,2 A population PK study conducted in patients with Primary Autonomic Failure indicated that increasing age was associated with decreased clearance of both droxidopa and 3 OM DOPS (Apparent clearance decreased 0.8% per year of age [referenced to age 65 years]). Further it was identified that patient's concurrently taking L-Dopa or dopamine derivatives had approximately 50% of the clearance seen with patients not taking droxidopa. 6 From a safety perspective, droxidopa has been generally very well-tolerated across a large variety of patient populations.
As a precursor of NE that can be administered orally, droxidopa is expected to provide a therapy for NOH in patients with autonomic failure associated with neurodegenerative diseases.
The Investigator's Brochure3 should be reviewed for a complete description of the non clinical and clinical experience with droxidopa.
2.0 Objectives 2.1 Primary Objective The primary objective of this study is to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and ESRD after a single oral dose compared to matched healthy subjects with normal renal function.
The PK parameters Cmax, Tmax, AUC(inf), CL/F, Vz/F, t½, and CLr are considered the primary parameters for evaluation.
2.2 Secondary Objective The secondary objective of this study is to assess the safety and tolerability of Droxidopa in matched healthy subjects and those with mild to severe renal dysfunction and ESRD through participant AEs and laboratory measures.
3.0 Investigational Plan 3.1 Study Description This study will be an open-label, single-treatment, single-dose, parallel group study to evaluate the PK of droxidopa in subjects with mild, moderate, and severe renal dysfunction and ESRD after a single dose compared to matched healthy subjects with normal renal function.
- Conditions
- Renal Disease, End Stage Renal Disease
- Being tested
- Droxidopa
- Medical subject headings
- Kidney Diseases, Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DroxidopaDrug
The dose to be used is a single 600 mg dose (2 x 300 mg capsules) of droxidopa.
| Study group | Role | What they receive |
|---|---|---|
| Normal renal function | Experimental | 16 subjects with normal renal function (eGFR greater than 90 mL/min/1.73m²) Receives: Drug: Droxidopa |
| Mild RD | Experimental | Eight (8) with mild (60 less than eGFR less than 89 mL/min/1.73m²) Receives: Drug: Droxidopa |
| Moderate RD | Experimental | Eight with moderate (30 less than eGFR less than 59 mL/min/1.73m²), Receives: Drug: Droxidopa |
| Severe RD | Experimental | Eight with severe (15 less than eGFR less than 29 mL/min/1.73m²) Receives: Drug: Droxidopa |
| End Stage Renal Disease | Experimental | Eight with ESRD (eGFR < 15 mL/min/1.73m² and requiring hemodialysis) Receives: Drug: Droxidopa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Objective Pharmacokinetic profile
The primary objective of this study is to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and ESRD after a single oral dose compared to matched healthy subjects with normal renal function.
The PK parameters Cmax, Tmax, AUC(inf), CL/F, Vz/F, t½, and CLr are considered the primary parameters for evaluation.
Measured: before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours
Secondary outcomes (1)
Secondary Objective Safety and tolerability
The secondary objective of this study is to assess the safety and tolerability of Droxidopa in matched healthy subjects and those with mild to severe renal dysfunction and ESRD through participant AEs and laboratory measures.
Measured: before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startOct 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal DiseaseStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chelsea Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- William D Schweiterman, MD, Study director, Chelsea Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468259
- Sponsor's protocol ID
- Droxidopa NOH103
- Status last verified
- Mar 2013
- First submitted
- 3 Nov 2011
- Last updated
- 29 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Multi-Center, Open-Label Study to Examine the Pharmacokinetics of a Single Dose of Droxidopa in Subjects With Renal Impairment Compared to Healthy Volunteers
- ClinicalTrials.gov ID
- NCT01468259
- Acronym / sponsor ID
- Droxidopa NOH103
- Conditions
- Renal Disease, End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Chelsea TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will be an open-label, single-treatment, single-dose, parallel group study to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and End Stage Renal Disease (ESRD) after a single dose compared to matched healthy subjects with normal renal function.
A total of 48 male or female subjects, 16 subjects with normal renal function (eGFR greater than 90 mL/min/1.73m²) and eight each (8) with mild (60 less than eGFR less than 89 mL/min/1.73m²), moderate (30 less than eGFR less than 59 mL/min/1.73m²), or severe (15 less than eGFR less than 29 mL/min/1.73m²) renal impairment or ESRD (eGFR < 15 mL/min/1.73m² and requiring hemodialysis) will be selected according to the inclusion and exclusion criteria. The medical and laboratory examinations will take place within 28 days before dosing. A single dose of 600 mg of droxidopa as an investigational drug will be administered with 240 mL of water after an overnight fast (minimum 10 hours).
Blood samples for the measurement of plasma concentrations of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours after dosing for healthy volunteers and subjects with mild, moderate, and severe renal impairment and those with ESRD. For the latter, samples will be collected on both a non-hemodialysis and a hemodialysis visit.
During dialysis, samples of dialysate, from the arterial and venous sides of the dialyzer will be collected at 30-minute intervals during the dialysis period. In addition, the entire dialysate will be collected, its volume recorded, and a sample retained for the measurement of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid concentrations.
Urine samples for the measurement of urinary excretion of droxidopa and metabolites including but not limited to 3-OM-DOPS, NE, vanillic acid, and protocatechuic acid will be collected before and over the following intervals after dosing: 0 2, 2-4, 4-6, 6-8, 8-12, 12-24, and 24-36 hours for healthy volunteers and subjects with mild, moderate, and severe renal impairment.
A post-study visit with physical examination and laboratory tests will take place within seven (7) days after the last PK blood sampling.
Detailed description
Introduction Droxidopa (L-DOPS) is an orally administered, synthetic catecholamine that is converted to the sympathetic neurotransmitter norepinephrine (NE) through a single step of decarboxylation by the endogenous enzyme 3,4-dihydroxyphenylalanine (DOPA) decarboxylase. Droxidopa was originally developed by Sumitomo Pharmaceuticals Co. Ltd., and has been marketed in Japan since 1989 for the indications listed below.
- Improvement of frozen gait and dizziness on standing up in patients with Parkinson's Disease.
- Improvement of orthostatic hypotension, syncope, and dizziness on standing up in patients with Shy-Drager syndrome and familial amyloid polyneuropathy.
- Improvement of the following symptoms of orthostatic hypotension in patients undergoing hemodialysis: dizziness, light-headed feeling, dizziness on standing up, malaise, and weakness.
Chelsea hypothesizes that these indications have an deficiency or lack of activity of the adrenergic neurotransmitter NE which can be affected by the use of a NE prodrug.
In Phase 1 clinical studies conducted in Japanese and Caucasian subjects, droxidopa was well tolerated and no differences were noted in oral absorption between the two groups. Apart from a moderate increase in heart rate in one Caucasian subject (receiving 600 mg droxidopa), which was considered to be possibly related to study medication, there were no other adverse events (AEs) that were considered to be related to droxidopa treatment. The maximum plasma concentration (Cmax) was reached between 2 and 3 hours after single, oral doses of droxidopa (100 to 900 mg). The plasma elimination half-life (t½) of droxidopa was 1.4 - 1.5 hours and approximately 15% of the drug was recovered unchanged in the urine. No drug accumulation was observed after multiple oral dosing with droxidopa (300 mg twice daily for 5 days).
Although the therapeutic effects of droxidopa are believed to be due to the conversion of droxidopa to NE, the major metabolite of droxidopa is methylated droxidopa (3-OM-DOPS).
After administration of single 100 mg and 300 mg doses to healthy volunteers, droxidopa, 3-OM-DOPS, and NE were observed in the urine. The 24-hour excretions of droxidopa and 3-OM-DOPS accounted for approximately 15% and 8% of the administered dose (3-OM-DOPS uncorrected for molecular weight), suggesting that renal function may impact the clearance of droxidopa and 3-OM-DOPS.1,2 A population PK study conducted in patients with Primary Autonomic Failure indicated that increasing age was associated with decreased clearance of both droxidopa and 3 OM DOPS (Apparent clearance decreased 0.8% per year of age [referenced to age 65 years]). Further it was identified that patient's concurrently taking L-Dopa or dopamine derivatives had approximately 50% of the clearance seen with patients not taking droxidopa. 6 From a safety perspective, droxidopa has been generally very well-tolerated across a large variety of patient populations.
As a precursor of NE that can be administered orally, droxidopa is expected to provide a therapy for NOH in patients with autonomic failure associated with neurodegenerative diseases.
The Investigator's Brochure3 should be reviewed for a complete description of the non clinical and clinical experience with droxidopa.
2.0 Objectives 2.1 Primary Objective The primary objective of this study is to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and ESRD after a single oral dose compared to matched healthy subjects with normal renal function.
The PK parameters Cmax, Tmax, AUC(inf), CL/F, Vz/F, t½, and CLr are considered the primary parameters for evaluation.
2.2 Secondary Objective The secondary objective of this study is to assess the safety and tolerability of Droxidopa in matched healthy subjects and those with mild to severe renal dysfunction and ESRD through participant AEs and laboratory measures.
3.0 Investigational Plan 3.1 Study Description This study will be an open-label, single-treatment, single-dose, parallel group study to evaluate the PK of droxidopa in subjects with mild, moderate, and severe renal dysfunction and ESRD after a single dose compared to matched healthy subjects with normal renal function.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Normal renal function | Experimental | Drug: Droxidopa16 subjects with normal renal function (eGFR greater than 90 mL/min/1.73m²) |
| Mild RD | Experimental | Drug: DroxidopaEight (8) with mild (60 less than eGFR less than 89 mL/min/1.73m²) |
| Moderate RD | Experimental | Drug: DroxidopaEight with moderate (30 less than eGFR less than 59 mL/min/1.73m²), |
| Severe RD | Experimental | Drug: DroxidopaEight with severe (15 less than eGFR less than 29 mL/min/1.73m²) |
| End Stage Renal Disease | Experimental | Drug: DroxidopaEight with ESRD (eGFR < 15 mL/min/1.73m² and requiring hemodialysis) |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Informed Consent
- Male or Female between 18 and 79 years
- Female subject of childbearing potential not surgically sterile or min 2 years postmenopausal must use approved contraceptives
- BMI 20 to 40 kg per m2
- Refrain from exercise
Key exclusion criteria (27 listed)
- Inability to complete study
- Insufficient venous access
- Clinically significant illness within 4 weeks of study
- History of clinically unstable disease except renal impairment in those subjects
- Medical or surgical conditions that may inhibit absorption of IP
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 |
|---|---|---|
| DroxidopaThe dose to be used is a single 600 mg dose (2 x 300 mg capsules) of droxidopa. | Drug | End Stage Renal Disease, Mild RD, Moderate RD, Normal renal function, Severe RD |
Primary outcome
Primary Objective Pharmacokinetic profile
Time frame: before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours
The primary objective of this study is to evaluate the pharmacokinetics (PK) of droxidopa in subjects with mild, moderate, and severe renal dysfunction and ESRD after a single oral dose compared to matched healthy subjects with normal renal function. The PK parameters Cmax, Tmax, AUC(inf), CL/F, Vz/F, t½, and CLr are considered the primary parameters for evaluation.
1 secondary outcome
Secondary Objective Safety and tolerability
Time frame: before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2013.
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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.
William D Schweiterman, MD study director
Chelsea Therapeutics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Droxidopa in people with Renal Disease and End Stage Renal Disease, run by Chelsea Therapeutics at 1 site in United States.
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 10 inclusion and 27 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: withdrawn, as of the sponsor's last update on 29 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Primary Objective Pharmacokinetic profile (time frame: before and 0, .5, 1, 1.5, 2, 3, 4, 5, 6, 8, 10, 12, 24, 30, 36 hours). 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 29 Mar 2013.