HypertensionPhase 1NCT01078376
A Comparative Single-Dose Pharmacokinetic (PK) and Safety Study of Azilsartan Medoxomil in Children With Hypertension and in Healthy Adults
A Phase 1 study testing Azilsartan medoxomil (TAK-491) in people with Hypertension, run by Takeda at 8 sites in 2 countries.
Trial summary
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults. Read more about this study
- Who is it for?
- Ages 1 year to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Azilsartan medoxomil (TAK-491)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 8 sitesin 2 countries
- Study dates
- May 2010to Sep 2013
- Phase
- Phase 1
- 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 1 year to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- For Pediatric Participants:
- Must have a diagnosis of hypertension (SBP and/or DBP ≥95th percentile for age/gender/height).
- For Cohorts 1 and 2 only, is within the weight range of 20 kg (44 pounds) to 100 kg (220 pounds), inclusive, at Screening.
- For Cohort 3 only, weighs at least 8.0 kg (17.6 pounds) at Screening.
- Participants greater than or equal to 6 years of age must have the ability to swallow a tablet of the size 6.0 millimeter diameter and 3.5 millimeter thickness.
- Has no known history of hepatitis B, hepatitis C, and human immunodeficiency virus.
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- For Cohort 3 only, may be renal transplant patient if all other inclusion and none of the exclusion criteria are met, along with additional criteria.
- Must have been at a constant weight, or expected weight gain for that particular age, for 30 days with no change to the dose of their diuretic drugs.
- For Healthy Adult Participants:
- Weighs at least 50 kilograms (110 pounds) and has a screening body mass index between 18 and 32 kilograms/m2, inclusive.
- Is in good health as determined by the physician
- Has a negative test result for hepatitis B surface antigen and antibody to hepatitis C virus, and has no known history of human immunodeficiency virus.
- Must have a negative urine test result for selected substances of abuse .
- Has a diastolic blood pressure between 60 and 90 mm Hg, inclusive, and a systolic blood pressure between 100 and 140 mm Hg, inclusive.
- For All Participants:
- Females of child bearing potential who are sexually active, as well as sexually active male participants, agree to routinely use adequate contraception from Screening until 30 days after receiving the last dose of study medication.
- Has clinical laboratory results within the reference range for the testing laboratory unless the results are deemed not clinically significant by the investigator.
Who cannot join
- For Pediatric Participants:
- Is currently treated with more than 2 antihypertensive agents.
- Has sitting trough clinic systolic blood pressure greater than 15 mm Hg or diastolic blood pressure greater than 10 mm Hg above the 99th percentile for age, gender, and height at Check-in .
- Has renovascular disease affecting both kidneys or a solitary kidney, dialysis treatment, severe nephrotic syndrome and not in remission.
- For Cohort 1 and 2 only, a previous renal transplant.
- Has a creatinine clearance less than 30 mL/min/1.73 m2.
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- For all participants:
- Has previously received azilsartan or azilsartan medoxomil.
- Has a known hypersensitivity or allergy to any angiotensin type II receptor blockers or to any of the excipients in the azilsartan medoxomil formulation to be taken.
- Has a history or clinical manifestations of severe cardiovascular disease, psychiatric disease, and any conditions that would interfere with gastrointestinal absorption.
- Has hemodynamically significant left ventricular outflow obstruction due to aortic valvular disease, cardiomyopathy, or uncorrected coarctation of the aorta.
- Has been diagnosed with malignant or accelerated hypertension.
- Has severe hepatic impairment.
- Has a serum albumin less than 2.5 g/dL.
- Has a glycosylated hemoglobin value greater than 8.5%.
- Has alanine aminotransferase, aspartate aminotransferase greater than 2 times the upper limit of normal, or total bilirubin greater than 1.5 times the upper limit of normal, active liver disease, or jaundice.
- Has hyperkalemia as defined by the laboratory normal reference range or any pertinent electrolyte disorders.
- Is participating in another investigational study or has taken an investigational drug within 30 days prior to Check-in .
- Has a history of drug abuse or a history of alcohol abuse within 1 year prior to study Check-in.
- Has a history of abdominal surgery or thoracic or nonperipheral vascular surgery within 6 months prior to study Check-in.
- Has a history of cancer, other than basal cell carcinoma or stage I squamous cell carcinoma of the skin that has not been in remission for at least 5 years prior to study Check-in.
- Has taken any cytotoxic drugs within 12 months prior to study Check-in .
- Has a history or presence of a clinically significant abnormal 12-lead electrocardiogram as determined by the investigator or sponsor/designee.
- Has poor peripheral venous access.
- Has any other condition or prior therapy that, in the opinion of the investigator, would make the participant unsuitable for the study.
- Has taken or requires the use of any medications, supplements, or food products within the stated time periods, including:
- Pediatric participants taking angiotensin-converting enzyme inhibitors and other angiotensin II receptor blockers will be required to withhold these medications from the morning of Day -1 until the 24 hour pharmacokinetic sample is completed on Day 2.
- Only pediatric participants will be allowed to take medications for primary renal or urologic conditions or hypertension as long as they have been on a stable dose of their medication for at least 30 days prior to Check-in (Day -1) and those medications are not potent cytochrome P-450 inhibitors or inducers.
- Nutraceuticals including herbal or dietary preparations such as ginseng, kava kava, and ginkgo biloba.
- Over-the-counter medications.
- Vitamin supplements except for pediatric participants only.
- Alcohol-containing products.
- Products that contain caffeine or xanthine-related compounds.
- Foods or beverages containing grapefruit juice or Seville-type oranges.
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
United States4 sites
Study site
Atlanta, Georgia
Study site
Little Rock, Arkansas
Study site
Louisville, Kentucky
Study site
Toledo, Ohio
United Kingdom4 sites
Study site
Birmingham, England
Study site
Bristol, England
Study site
London, England
Study site
Manchester, England
About this study
Official title: A Comparative Single-Dose Pharmacokinetic and Safety Study of TAK-491 Between Infants, Children, and Adolescents With Hypertension and Healthy Adults
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
Read the detailed description
Within the past 10 years, the incidence of high blood pressure (hypertension) in children and adolescents has increased all over the world. This increase is connected in part to a growing number of people who are overweight and do not eat right or exercise enough. In younger children though, high blood pressure is a common consequence of underlying diseases, such as renal diseases.
This study looked at a blood pressure medicine called TAK-491 (azilsartan medoxomil) to see how it works in children who have hypertension. Azilsartan medoxomil is a prodrug that converts into TAK-536 (azilsartan), a blood pressure lowering medicine that had not been tested in children.
To be eligible to take part in this study, children with a diagnosis of hypertension (primary or secondary) must have been between the ages of 1 year and 16 years old (up to their 17th birthday). Each child was given one dose of azilsartan medoxomil, followed by a number of blood tests and assessments within 24 hours after taking azilsartan medoxomil to see how the medication is working. Adults who do not have hypertension also took part in this study to provide comparison.
This study took place in 9 sites in the UK and USA. A total of 20 children with hypertension and 9 adults without hypertension participated in this study.
This study lasted about 43 days. This included a 28 day screening period, a 2 day treatment phase and a follow up period. Each participant taking part in this study may have been requested to remain in a hospital for one overnight stay during the course of the study. Each participant was contacted by telephone 6 days and 15 days after taking azilsartan medoxomil.
Takeda has decided to close Cohort 3 (participants between 1 and 6 years of age with hypertension) enrollment early and end this study with the agreement of both the US Food and Drug Administration (FDA) and the Pediatric Committee (PDCO) at the European Medicines Agency. Requests to the FDA and PDCO were submitted to close the study without completion of enrollment in Cohort 3 due to difficulty enrolling this particular patient population. Takeda proposed an alternative option to collect PK data in this age subset by utilizing PK modeling to determine the appropriate doses in children 1-5 years of age in lieu of completing Cohort 3. The FDA and PDCO agreed with this approach.
- Conditions
- Hypertension
- Being tested
- Azilsartan medoxomil (TAK-491)
- Keywords
- Pediatrics, Blood Pressure, High, Drug Therapy
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Azilsartan medoxomil (TAK-491)Drug
Also called TAK-491
Azilsartan medoxomil 80 mg, tablets, orally, one day only
Azilsartan medoxomil (TAK-491)Drug
Also called TAK-491
Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only
Azilsartan medoxomil (TAK-491)Drug
Also called TAK-491
Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only
Azilsartan medoxomil (TAK-491)Drug
Also called TAK-491
Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: Healthy Adults (18 years to 45 years old) | Experimental | Azilsartan medoxomil 80 mg, tablets, orally, one day only Receives: Drug: Azilsartan medoxomil (TAK-491) |
| Cohort 1: Adolescents (≥12 to <17 years old) | Experimental | Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only Receives: Drug: Azilsartan medoxomil (TAK-491) |
| Cohort 2: Children (≥6 to <12 years old) | Experimental | Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only Receives: Drug: Azilsartan medoxomil (TAK-491) |
| Cohort 3: Children (≥1 to <6 years old) | Experimental | Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only Receives: Drug: Azilsartan medoxomil (TAK-491) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Measured: Day 1
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Measured: Day 1
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Measured: Day 1
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Measured: Day 1
Maximum Observed Plasma Concentration (Cmax) for TAK-536
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1
Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Measured: Day 1
Time to Reach Cmax (Tmax) for TAK-536
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Measured: Day 1
Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Measured: Day 1
Terminal Elimination Half-life (T1/2) for TAK-536
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Day 1
Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Measured: Day 1
Apparent Oral Clearance (CL/F) for TAK-536
CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.
Measured: Day 1
Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Measured: Day 1
Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Measured: Day 1
Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.
Measured: Day 1
Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.
Measured: Day 1
Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Measured: Day 1
Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2010 (estimated)
- Study startMay 2010
- Primary completionJul 2013
- Study completionSep 2013
Why it stopped: Business Decision (see below)
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 HypertensionStudies of the same condition, open and under way.
- More trials run by TakedaThe 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
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Takeda
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Takeda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01078376
- Sponsor's protocol ID
- TAK-491_109
- Other IDs
- 2009-013165-25, U1111-1113-4416, 2009
- Status last verified
- Jun 2014
- First submitted
- 26 Feb 2010
- Last updated
- 25 Jul 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Single-Dose Pharmacokinetic and Safety Study of TAK-491 Between Infants, Children, and Adolescents With Hypertension and Healthy Adults
- ClinicalTrials.gov ID
- NCT01078376
- Acronym / sponsor ID
- TAK-491_109
- Conditions
- Hypertension
- Keywords
- Pediatrics, Blood Pressure, High, Drug Therapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Business Decision (see below)
- Enrolment
- 29 participants (actual)
- Lead sponsor
- TakedaIndustry (pharma, biotech, devices)
- Study start
- May 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 2 Mar 2010 (estimated)
- Results
- Posted 25 Jul 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study was to assess the pharmacokinetics (PK) and safety of a single dose of azilsartan medoxomil in children with hypertension, and comparative PK in healthy adults.
Detailed description
Within the past 10 years, the incidence of high blood pressure (hypertension) in children and adolescents has increased all over the world. This increase is connected in part to a growing number of people who are overweight and do not eat right or exercise enough. In younger children though, high blood pressure is a common consequence of underlying diseases, such as renal diseases.
This study looked at a blood pressure medicine called TAK-491 (azilsartan medoxomil) to see how it works in children who have hypertension. Azilsartan medoxomil is a prodrug that converts into TAK-536 (azilsartan), a blood pressure lowering medicine that had not been tested in children.
To be eligible to take part in this study, children with a diagnosis of hypertension (primary or secondary) must have been between the ages of 1 year and 16 years old (up to their 17th birthday). Each child was given one dose of azilsartan medoxomil, followed by a number of blood tests and assessments within 24 hours after taking azilsartan medoxomil to see how the medication is working. Adults who do not have hypertension also took part in this study to provide comparison.
This study took place in 9 sites in the UK and USA. A total of 20 children with hypertension and 9 adults without hypertension participated in this study.
This study lasted about 43 days. This included a 28 day screening period, a 2 day treatment phase and a follow up period. Each participant taking part in this study may have been requested to remain in a hospital for one overnight stay during the course of the study. Each participant was contacted by telephone 6 days and 15 days after taking azilsartan medoxomil.
Takeda has decided to close Cohort 3 (participants between 1 and 6 years of age with hypertension) enrollment early and end this study with the agreement of both the US Food and Drug Administration (FDA) and the Pediatric Committee (PDCO) at the European Medicines Agency. Requests to the FDA and PDCO were submitted to close the study without completion of enrollment in Cohort 3 due to difficulty enrolling this particular patient population. Takeda proposed an alternative option to collect PK data in this age subset by utilizing PK modeling to determine the appropriate doses in children 1-5 years of age in lieu of completing Cohort 3. The FDA and PDCO agreed with this approach.
Study design
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Healthy Adults (18 years to 45 years old) | Experimental | Drug: Azilsartan medoxomil (TAK-491)Azilsartan medoxomil 80 mg, tablets, orally, one day only |
| Cohort 1: Adolescents (≥12 to <17 years old) | Experimental | Drug: Azilsartan medoxomil (TAK-491)Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only |
| Cohort 2: Children (≥6 to <12 years old) | Experimental | Drug: Azilsartan medoxomil (TAK-491)Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only |
| Cohort 3: Children (≥1 to <6 years old) | Experimental | Drug: Azilsartan medoxomil (TAK-491)Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (17 listed)
- Must have a diagnosis of hypertension (SBP and/or DBP ≥95th percentile for age/gender/height).
- For Cohorts 1 and 2 only, is within the weight range of 20 kg (44 pounds) to 100 kg (220 pounds), inclusive, at Screening.
- For Cohort 3 only, weighs at least 8.0 kg (17.6 pounds) at Screening.
- Participants greater than or equal to 6 years of age must have the ability to swallow a tablet of the size 6.0 millimeter diameter and 3.5 millimeter thickness.
- Has no known history of hepatitis B, hepatitis C, and human immunodeficiency virus.
Key exclusion criteria (34 listed)
- Is currently treated with more than 2 antihypertensive agents.
- Has sitting trough clinic systolic blood pressure greater than 15 mm Hg or diastolic blood pressure greater than 10 mm Hg above the 99th percentile for age, gender, and height at Check-in .
- Has renovascular disease affecting both kidneys or a solitary kidney, dialysis treatment, severe nephrotic syndrome and not in remission.
- For Cohort 1 and 2 only, a previous renal transplant.
- Has a creatinine clearance less than 30 mL/min/1.73 m2.
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 |
|---|---|---|
| Azilsartan medoxomil (TAK-491)Also: TAK-491Azilsartan medoxomil 80 mg, tablets, orally, one day only | Drug | Cohort 1: Healthy Adults (18 years to 45 years old) |
| Azilsartan medoxomil (TAK-491)Also: TAK-491Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only | Drug | Cohort 1: Adolescents (≥12 to <17 years old) |
| Azilsartan medoxomil (TAK-491)Also: TAK-491Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only | Drug | Cohort 2: Children (≥6 to <12 years old) |
| Azilsartan medoxomil (TAK-491)Also: TAK-491Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only | Drug | Cohort 3: Children (≥1 to <6 years old) |
Primary outcome
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536
Time frame: Day 1
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 Metabolite M-II.
Time frame: Day 1
AUC(0-tlqc) is a measure of total plasma exposure to the drug from Time 0 to Time of the Last Quantifiable Concentration (AUC[0-tlqc]).
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536
Time frame: Day 1
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Area Under the Plasma Concentration-time Curve From Time 0 to Infinity (AUC[0-inf]) for TAK-536 Metabolite M-II
Time frame: Day 1
Area under the plasma concentration-time curve from time 0 to infinity, calculated as AUC(0-inf)=AUC(0-tlqc) + Clast/λz.
Maximum Observed Plasma Concentration (Cmax) for TAK-536
Time frame: Day 1
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Maximum Observed Plasma Concentration (Cmax) for TAK-536 Metabolite M-II
Time frame: Day 1
Maximum observed plasma concentration (Cmax) is the peak plasma concentration of a drug after administration, obtained directly from the plasma concentration-time curve.
Time to Reach Cmax (Tmax) for TAK-536
Time frame: Day 1
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Time to Reach Cmax (Tmax) for TAK-536 Metabolite M-II
Time frame: Day 1
Tmax: Time to reach the maximum plasma concentration (Cmax), equal to time (hours) to Cmax, as observed on Day 1.
Terminal Elimination Half-life (T1/2) for TAK-536
Time frame: Day 1
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Terminal Elimination Half-life (T1/2) for TAK-536 Metabolite M-II
Time frame: Day 1
Terminal phase elimination half-life (T1/2) is the time required for half of the drug to be eliminated from the plasma.
Apparent Oral Clearance (CL/F) for TAK-536
Time frame: Day 1
CL/F is apparent clearance of the drug from the plasma, expressed in L/hr.
Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Time frame: Day 1
Total Amount of Drug Excreted in Urine From Time 0 to 24 Hours Postdose (Ae[0-t]) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Time frame: Day 1
Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Time frame: Day 1
Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.
Fraction of Unchanged Drug Excreted in Urine From 0 to 24 Hours Postdose (Fe%) (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Time frame: Day 1
Fe=[Ae(0-24)/dose]×100 (molecular weight adjusted for metabolites.
Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536)
Time frame: Day 1
Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Renal Clearance (CLr) From 0 to 24 Hours Postdose (for Cohorts 1 and 2 Urine Pharmacokinetic Endpoint for TAK-536 Metabolite M-II)
Time frame: Day 1
Renal clearance, calculated as CLr=Ae(0-24)/AUC(0-24).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Medical Director study director
Takeda
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Azilsartan medoxomil (TAK-491) in people with Hypertension, run by Takeda at 8 sites in 2 countries.
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 17 inclusion and 34 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: stopped early, as of the sponsor's last update on 25 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, United Kingdom. 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?
Yes. Results are posted in the registry (first posted 25 Jul 2014). 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?
Area Under the Plasma Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration (AUC[0-tlqc]) for TAK-536 (time frame: Day 1). The study lists 17 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 25 Jul 2014; AzTrials last refreshed its copy on 3 Nov 2026.