Clinical trial NCT01078376
Conditions: Hypertension
Keywords: Pediatrics Blood Pressure, High Drug Therapy
Sponsor: Takeda
Start date: 2010-05-01; Completion date: 2013-09-01
Enrollment: 29 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief 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.

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.

Arms: arm 1: Azilsartan medoxomil 80 mg, tablets, orally, one day only arm 2: Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only arm 3: Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only arm 4: Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only
Interventions: intervention 1: Azilsartan medoxomil (TAK-491) intervention 2: Azilsartan medoxomil (TAK-491) intervention 3: Azilsartan medoxomil (TAK-491) intervention 4: Azilsartan medoxomil (TAK-491)
Intervention descriptions: intervention 1: Azilsartan medoxomil 80 mg, tablets, orally, one day only intervention 2: Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only intervention 3: Azilsartan medoxomil 20 mg to 60 mg (based on participant weight), tablets, orally, one day only intervention 4: Azilsartan medoxomil 0.66 mg/kg participant body weight, granules, reconstituted orally, one day only

Protocol documents: