Renal InsufficiencyPhase 1NCT02182024
Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Dabigatran Etexilate in Patients With and Without Renal Impairment
A Phase 1 study testing Dabigatran etexilate high dose and Dabigatran etexilate low dose in people with Renal Insufficiency, run by Boehringer Ingelheim.
Trial summary
To assess the effect of different degrees of renal impairment on the pharmacokinetics and pharmacodynamics of dabigatran etexilate administered orally. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Renal Insufficiency
- What is being tested?
- Dabigatran etexilate high dose and Dabigatran etexilate low dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Mar 2006
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male or female subjects determined by results of screening with a creatinine clearance >80 mL/min (group 1, control group)
- Renally impaired male or female subjects determined by results of screening with the following creatinine clearance results:
- creatinine clearance >50 - ≤80 mL/min (group 2)
- creatinine clearance >30 - ≤50 mL/min (group 3)
- creatinine clearance ≤30 mL/min (group 4)
- uraemia requiring maintenance dialysis (group 5)
Show all 9Show fewer
- Signed written informed consent in accordance with Good Clinical Practice (GCP) and local legislation
- Age >=18 and <=75 years
- BMI >=18.0 and <=32 kg/m2, at least 45 kg for females
Who cannot join
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy, cholecystectomy or herniotomy)
- Clinically relevant diseases of the central nervous system
- Relevant history of orthostatic hypotension, fainting spells or blackouts
- Abnormal prothrombin time (PT), TT, aPTT (must be within the normal range after no more than one repeated test), thrombocytes <150000/μl (two repeats of the first test)
Show all 36Show fewer
- Evidence of haematuria either macroscopically detectable or microscopic on urinalysis (normal microscopic results after no more than one repeated test)
- Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, central nervous system (CNS) trauma, retinopathy or nephrolithiasis)
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- For women with childbearing potential: no reliable contraception (accepted methods are intra uterine device, hormonal contraceptives, bilateral tubal ligation, hysterectomy, condoms) or pregnancy (known or detected by a positive pregnancy test) or breast feeding period
- Intake of drugs with a long half-life (>24 hours) (<1 month prior to administration or during the trial)
- Use of any drugs, within 14 days prior to administration or during the trial
- Participation in another trial with an investigational drug (<2 months prior to drug administration or during trial)
- Drug abuse
- Blood donation or loss >400 mL, <1 month prior to administration or during the trial
- Excessive physical activities <5 days prior to administration of study drug or during trial
- Clinically relevant laboratory abnormalities
- Renally impaired subjects (groups 2, 3, 4 and 5) who met any of the following criteria were not be entered into this trial:
- Moderate and severe concurrent liver function impairment (e.g. due to hepatorenal syndrome)
- Clinically relevant gastrointestinal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy, cholecystectomy or herniotomy)
- Clinically relevant diseases of the central nervous system
- Relevant history of orthostatic hypotension, fainting spells or blackouts
- Abnormal values for PT, TT, aPTT and thrombocytes considered by the investigator or one of the co-investigators to be clinically relevant
- Evidence of blood dyscrasia, haemorrhagic diathesis, severe thrombocytopenia, cerebrovascular haemorrhage, bleeding tendencies associated with active ulceration or overt bleeding of gastrointestinal, respiratory or genitourinary tract or any disease or condition with haemorrhagic tendencies (e.g. cerebral aneurysm, dissecting aorta, CNS trauma, retinopathy, nephrolithiasis) considered by the investigator or one of the co-investigators to be clinically relevant
- Recent or contemplated diagnostic or therapeutic procedures with potential for uncontrollable bleeding (e.g. spinal puncture, lumbar block anaesthesia, surgery of CNS or eye or surgery resulting in large open surfaces) within 14 days before or after drug administration of this clinical trial
- Chronic or relevant acute infections
- History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
- For women with childbearing potential: no reliable contraception (accepted methods are intra-uterine device, hormonal contraceptives, bilateral tubal ligation, hysterectomy or condoms) or pregnancy (known or detected by a positive pregnancy test) or breast-feeding period
- Participation in another trial with an investigational drug (<2 months prior to administration or during trial)
- Drug abuse
- Blood donation or loss >400 mL, <1 month prior to administration or during the trial
- Excessive physical activities < 5 days prior to administration of study drug or during trial
- Clinically relevant laboratory abnormalities except those values typical for renally impaired patients
About this study
Official title: Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of 150 mg Dabigatran Etexilate p.o. in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open, Parallel-group Trial
To assess the effect of different degrees of renal impairment on the pharmacokinetics and pharmacodynamics of dabigatran etexilate administered orally.
- Conditions
- Renal Insufficiency
- Being tested
- Dabigatran etexilate high dose, Dabigatran etexilate low dose
- Medical subject headings
- Renal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dabigatran etexilate high doseDrug
Dabigatran etexilate low doseDrug
| Study group | Role | What they receive |
|---|---|---|
| Dabigatran high dose in healthy subjects | Experimental | healthy subjects with a creatinine clearance of >80 mL/m Receives: Drug: Dabigatran etexilate high dose |
| Dabigatran high dose in mild renal impairment | Experimental | patients with a creatinine clearance of >50 up to 80 mL/min Receives: Drug: Dabigatran etexilate high dose |
| Dabigatran high dose in moderate renal impairment | Experimental | patients with a creatinine clearance of >30 up to 50 mL/min Receives: Drug: Dabigatran etexilate high dose |
| Dabigatran high dose in severe renal impairment | Experimental | patients with a creatinine clearance of up to 30 mL/min Receives: Drug: Dabigatran etexilate high dose |
| Dabigatran low dose in haemodialysis patients | Experimental | patients requiring haemodialysis Receives: Drug: Dabigatran etexilate low dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC0-infinity (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Cmax (maximum concentration of the analyte in plasma)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
international normalized ratio (INR)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
activated partial thromboplastin time (aPTT)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Ecarin clotting time (ECT)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
thrombin time (TT)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Secondary outcomes (17)
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2, time interval to be determined)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
tmax (time from dosing to the maximum concentration of the analyte in plasma, oral administration only)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
λz (terminal rate constant in plasma)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
t1/2 (terminal half-life of the analyte in plasma)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Measured: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Ae0-72 (amount of analyte that is eliminated in urine from the time interval 0 to 72 h)
Measured: pre-dose over 12 hours and post dose in fractions of 0 - 12, 12 - 24, 24 - 48, and 48-72 h, additional until 96 h in subjects with severe renal impairment
fe0-72 (fraction of administered drug excreted unchanged in urine from time point 0 to 72 h)
Measured: pre-dose over 12 hours and post dose in fractions of 0 - 12, 12 - 24, 24 - 48, and 48-72 h, additional until 96 h in subjects with severe renal impairment
CLR,0-72 (renal clearance of the analyte in plasma from the time point 0 h until the timepoint 72 h)
Measured: pre-dose over 12 hours and post dose in fractions of 0 - 12, 12 - 24, 24 - 48, and 48-72 h, additional until 96 h in subjects with severe renal impairment
Plasma protein binding of dabigatran
Measured: within 1 h before study drug administration
Changes from baseline in pulse rate
Measured: Day 4, Day 5 in patients with renal impairment
Changes from baseline in systolic and diastolic blood pressure
Measured: Day 4, Day 5 in patients with renal impairment
Changes from baseline in ECG
Measured: Day 4, Day 5 in patients with renal impairment
Changes from baseline in routine laboratory
Measured: Day 4, Day 5 in patients with renal impairment
Occurrence of adverse events
Measured: up to day 4, up to day 5 in patients with renal impairment
Assessment of tolerability on a 4-point scale
Measured: Day 4, Day 5 in patients with renal impairment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2014 (estimated)
- Study startApr 2005
- Primary completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal InsufficiencyStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02182024
- Sponsor's protocol ID
- 1160.23
- Status last verified
- Jul 2014
- First submitted
- 2 Jul 2014
- Last updated
- 18 Jul 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of 150 mg Dabigatran Etexilate p.o. in Patients With Different Degrees of Renal Impairment in Comparison to Subjects With Normal Renal Function in a Monocentric, Open, Parallel-group Trial
- ClinicalTrials.gov ID
- NCT02182024
- Acronym / sponsor ID
- 1160.23
- Conditions
- Renal Insufficiency
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Apr 2005
- Primary completion
- Mar 2006 (actual)
- First posted
- 8 Jul 2014 (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.
To assess the effect of different degrees of renal impairment on the pharmacokinetics and pharmacodynamics of dabigatran etexilate administered orally.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Dabigatran high dose in healthy subjects | Experimental | Drug: Dabigatran etexilate high dosehealthy subjects with a creatinine clearance of >80 mL/m |
| Dabigatran high dose in mild renal impairment | Experimental | Drug: Dabigatran etexilate high dosepatients with a creatinine clearance of >50 up to 80 mL/min |
| Dabigatran high dose in moderate renal impairment | Experimental | Drug: Dabigatran etexilate high dosepatients with a creatinine clearance of >30 up to 50 mL/min |
| Dabigatran high dose in severe renal impairment | Experimental | Drug: Dabigatran etexilate high dosepatients with a creatinine clearance of up to 30 mL/min |
| Dabigatran low dose in haemodialysis patients | Experimental | Drug: Dabigatran etexilate low dosepatients requiring haemodialysis |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Healthy male or female subjects determined by results of screening with a creatinine clearance >80 mL/min (group 1, control group)
- Renally impaired male or female subjects determined by results of screening with the following creatinine clearance results:
- Age >=18 and <=75 years
- BMI >=18.0 and <=32 kg/m2, at least 45 kg for females
Key exclusion criteria (36 listed)
- Any finding of the medical examination (including blood pressure, pulse rate, and electrocardiogram) deviating from normal and of clinical relevance
- Clinically relevant gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunologic or hormonal disorders
- Surgery of gastrointestinal tract (except appendectomy, cholecystectomy or herniotomy)
- Clinically relevant diseases of the central nervous system
- Relevant history of orthostatic hypotension, fainting spells or blackouts
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 |
|---|---|---|
| Dabigatran etexilate high dose | Drug | Dabigatran high dose in healthy subjects, Dabigatran high dose in mild renal impairment, Dabigatran high dose in moderate renal impairment, Dabigatran high dose in severe renal impairment |
| Dabigatran etexilate low dose | Drug | Dabigatran low dose in haemodialysis patients |
Primary outcome
AUC0-infinity (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Cmax (maximum concentration of the analyte in plasma)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
CL/F (apparent clearance of the analyte in the plasma after extravascular administration)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
international normalized ratio (INR)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
activated partial thromboplastin time (aPTT)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Ecarin clotting time (ECT)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
thrombin time (TT)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
17 secondary outcomes
AUC0-tz (area under the concentration-time curve of the analyte in plasma over the time interval from 0 to the time of the last quantifiable data point)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
AUCt1-t2 (area under the concentration-time curve of the analyte in plasma over the time interval t1 to t2, time interval to be determined)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
tmax (time from dosing to the maximum concentration of the analyte in plasma, oral administration only)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
λz (terminal rate constant in plasma)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
t1/2 (terminal half-life of the analyte in plasma)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
MRTpo (mean residence time of the analyte in the body after p.o. administration)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Vz/F (apparent volume of distribution during the terminal phase λz following an extravascular dose)
Time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients
Ae0-72 (amount of analyte that is eliminated in urine from the time interval 0 to 72 h)
Time frame: pre-dose over 12 hours and post dose in fractions of 0 - 12, 12 - 24, 24 - 48, and 48-72 h, additional until 96 h in subjects with severe renal impairment
fe0-72 (fraction of administered drug excreted unchanged in urine from time point 0 to 72 h)
Time frame: pre-dose over 12 hours and post dose in fractions of 0 - 12, 12 - 24, 24 - 48, and 48-72 h, additional until 96 h in subjects with severe renal impairment
CLR,0-72 (renal clearance of the analyte in plasma from the time point 0 h until the timepoint 72 h)
Time frame: pre-dose over 12 hours and post dose in fractions of 0 - 12, 12 - 24, 24 - 48, and 48-72 h, additional until 96 h in subjects with severe renal impairment
Plasma protein binding of dabigatran
Time frame: within 1 h before study drug administration
Changes from baseline in pulse rate
Time frame: Day 4, Day 5 in patients with renal impairment
Changes from baseline in systolic and diastolic blood pressure
Time frame: Day 4, Day 5 in patients with renal impairment
Changes from baseline in ECG
Time frame: Day 4, Day 5 in patients with renal impairment
Changes from baseline in routine laboratory
Time frame: Day 4, Day 5 in patients with renal impairment
Occurrence of adverse events
Time frame: up to day 4, up to day 5 in patients with renal impairment
Assessment of tolerability on a 4-point scale
Time frame: Day 4, Day 5 in patients with renal impairment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dabigatran etexilate high dose and Dabigatran etexilate low dose in people with Renal Insufficiency, run by Boehringer Ingelheim.
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 9 inclusion and 36 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 18 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
AUC0-infinity (area under the concentration time curve of the analyte in plasma over the time interval from 0 extrapolated to infinity) (time frame: pre-dose and 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 48 and 72 h after administration, additional 96 h in subjects with severe renal impairment and dialysis patients). The study lists 7 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 18 Jul 2014.