New drug dotinurad takes on febuxostat in battle for heart health
NCT ID NCT06834230
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether dotinurad is better than febuxostat at improving blood vessel stiffness in 360 adults with high uric acid and high blood pressure. Participants will take one of the two drugs for 24 weeks. The goal is to see which drug better controls uric acid and supports heart health.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
-
About 360 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Mar 2025
- Expected to finish
-
Mar 2030
An estimate. End dates often move.
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
20 years and older
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients aged 20 years or older at the time of consent (regardless of gender) 2. 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 of obtaining consent but have been off the drugs for more than 27 days 3. 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) has not changed within 4 weeks prior to eligibility determination 4. Patients who have given written consent to participate in this study Exclusion Criteria: 1. Patients with unsettled gout after acute gouty arthritis 2. Patients currently suffering from urinary tract stones 3. Patients with known secondary hyperuricemia who have Lesch-Nyhan syndrome, hyperphosphoribosyl pyrophosphate synthase, congenital myogenic hyperuricemia, hematopoietic tumors (acute leukemia, malignant lymphoma, myeloproliferative disorders, myelodysplastic syndrome), solid tumors (breast cancer, seminoma, sarcoma, Wilms' tumor, small cell lung cancer), non-neoplastic diseases (psoriasis vulgaris, secondary polycythemia vera, hemolytic anemia), tumor melting syndrome, rhabdomyolysis, hypothyroidism, polycystic kidney disease, lead poisoning/lead nephropathy, Down syndrome, familial juvenile gout nephropathy, hyperlactatemia, or type 1 glycogenic disease 4. Patients with hypertensive emergencies and urgency 5. Patients with active malignancies 6. Patients with severe hepatic dysfunction 7. Patients with severe renal dysfunction with oliguria or anuria 8. Pregnant, possibly pregnant, or lactating patients 9. Patients with a history of hypersensitivity to the components of dotinurad and febuxostat 10. Patients receiving mercaptopurine hydrate or azathioprine 11. Other patients deemed inappropriate for this study by the investigator
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Hypertension are added.
By submitting, you agree to our Terms of use
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
-
Saga University
RECRUITINGSaga, Saga-ken, 840-8502, Japan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Personalized coaching via smartphone could curb hypertension before it starts
- Can AI help nurses guide At-Risk seniors to better care and lower costs?
- Can stress explain the link between obesity and high blood pressure?
- Can a herbal formula match traditional medicine for brain bleeds?
- Could a helping hand with housing and food cut hospital visits?
- Brain scans and peer support: a new test for beating high blood pressure in african american women