CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 10 enrolled
Drug / intervention
TAK-536drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04668157
NCT04668157Phase 3Completed
CompareCT.gov

A Phase 3, Open-label, Multicenter, Long-term Study to Evaluate the Safety, Efficacy and Pharmacokinetics of TAK-536 in Pediatric Subjects From 2 to Less Than 6 Years of Age With Hypertension

Takeda·interventional·Posted Dec 16, 2020·Updated Dec 9, 2024

In Brief

A Phase 3 clinical trial evaluating TAK-536 for Hypertension. Completed, enrolled 10 participants across 19 sites.

Detailed Summary

The main aim of this study is to check the safety of TAK-536. This study will take place in Japan. At the first visit, the study doctor will check if each child can take part. For those who can take part, each participant will have a check-up by the study doctor. After this, each participant will take placebo. This might take 2 weeks. After this, parents or the caregivers of each participant will be given sachets that contain granules of TAK-536 to give to that participant. The participants will take the TAK-536 granules once a day for 52 weeks. After treatment has finished, participants will visit the study clinic for a final check-up.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesJapan
Collaborators--

Timeline

Phase 3CompletedFinished
202120222023202420252026
First PostedDec 16, 2020
Enrollment StartMay 17, 2021
Primary CompletionDec 28, 2023
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 5.5 years ago

Interventions

TAK-536drug

TAK-536 granule formulation