Effect of Dotinurad in Hyperuricemia With Hypertension

ConditionsHyperuricemia or Gout Hypertension

Trial statusRecruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age20+

SponsorSaga University

About this trial

The effect of dotinurad on CAVI (cardio-ankle vascular index) will be compared with that of febuxostat in patients with hyperuricemia complicated by hypertension.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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 of obtaining consent but have been off the drugs for more than 27 days

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

Patients who have given written consent to participate in this study

Disqualifiers

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, 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

Patients with hypertensive emergencies and urgency

Trial design

Design model

Parallel

Treatments tested in this trial

Dotinurad
Drug
Start at 0.5 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (2 mg once daily).
Febuxostat
Drug
Start at 10 mg once daily, and then referring to the attached document, gradually increase the dose to the maintenance dose (40 mg once daily).

Treatment groups

360 Participants

are divided into 2 treatment groups

Group A: DotinuradExperimental treatment 1 intervention

Group B: FebuxostatActive comparator 1 intervention

Trial outcomes

Primary outcomes

Change in CAVI

Change in CAVI at 24 weeks after study drug administration

Time frame

24 weeks

Secondary outcomes

Change in CAVI category

Change in CAVI category (\<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) at 24 weeks after study drug administration (key secondary endpoint)

Time frame

24 weeks

Change in CAVI

Change in CAVI at 12 weeks after study drug administration

Time frame

12 weeks

Change in CAVI category

Change in CAVI category (\<8.0: normal, 8.0 to 9.0: borderline, 9.0 or greater: abnormal) at 12 weeks after study drug administration

Time frame

12 weeks

Other outcomes

Changes in serum uric acid levels

Changes in serum uric acid levels at 4, 8, 12 and 24 weeks after study drug administration

Time frame

4, 8, 12 and 24 weeks

Percentage of patients whose serum uric acid levels reach 6.0 mg/dL or less

Percentage of patients whose serum uric acid levels reach 6.0 mg/dL or less at 4, 8, 12, and 24 weeks after study drug administration

Time frame

4, 8, 12 and 24 weeks

Change in AI

Change in AI at 24 weeks after study drug administration

Time frame

24 weeks

Change in %MAP

Change in %MAP at 24 weeks after study drug administration

Time frame

24 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Saga University

Lead sponsor

Source ClinicalTrials.gov

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