Recruiting PHASE4 Hyperuricemia or Gout

New treatment option for Hyperuricemia or Gout

Official title Effect of Dotinurad in Hyperuricemia With Hypertension

ClinicalTrials.gov ID: NCT06834230

What this study is testing

What is Dotinurad?

Dotinurad is an investigational medicine, given as an once-daily, being studied as a potential treatment for hyperuricemia or gout.

Also referred to as URECE.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.
  • Phase 4: studies an already-approved treatment
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 20 and older

You may be able to join if

  • Patients aged 20 years or older at the time of consent (regardless of gender)
  • Patients with hyperuricemia with serum uric acid level \>7.0 mg/dL who have not received any urate lowering drug within 27 days prior to obtaining...
  • Hypertensive patients who meet the definition of hypertension in the latest Hypertension Treatment Guidelines of the Japanese Society of Hypertension...
  • Patients who have given written consent to participate in this study

You likely can't join if

  • Patients with unsettled gout after acute gouty arthritis
  • Patients currently suffering from urinary tract stones
  • Patients with known secondary hyperuricemia who have Lesch-Nyhan syndrome, hyperphosphoribosyl pyrophosphate synthase, congenital myogenic...
  • Patients with hypertensive emergencies and urgency
  • Patients with active malignancies
  • Patients with severe hepatic dysfunction
See the full eligibility criteria
Who can join
  • Patients aged 20 years or older at the time of consent (regardless of gender)
  • Patients with hyperuricemia with serum uric acid level \>7.0 mg/dL who have not received any urate lowering drug within 27 days prior to obtaining consent, or patients who were receiving urate lowering drugs at the time...
  • Hypertensive patients who meet the definition of hypertension in the latest Hypertension Treatment Guidelines of the Japanese Society of Hypertension and whose treatment for hypertension (with or without drug therapy)...
  • Patients who have given written consent to participate in this study
What rules you out
  • Patients with unsettled gout after acute gouty arthritis
  • Patients currently suffering from urinary tract stones
  • Patients with known secondary hyperuricemia who have Lesch-Nyhan syndrome, hyperphosphoribosyl pyrophosphate synthase, congenital myogenic hyperuricemia, hematopoietic tumors (acute leukemia, malignant lymphoma...
  • Patients with hypertensive emergencies and urgency
  • Patients with active malignancies
  • Patients with severe hepatic dysfunction
  • Patients with severe renal dysfunction with oliguria or anuria
  • Pregnant, possibly pregnant, or lactating patients
  • Patients with a history of hypersensitivity to the components of dotinurad and febuxostat
  • Patients receiving mercaptopurine hydrate or azathioprine
  • Other patients deemed inappropriate for this study by the investigator

The study team makes the final eligibility decision.

Where it's taking place

  • Saga, Saga-ken, Japan

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 20 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Saga, Saga-ken, Japan. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.