Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Gout and Hyperuricemia

Treatments: Drug: Allopurinol; Drug: RDEA3170; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02078219

D5491C00001

RDEA3170-203 (Other Identifier)

Details and patient eligibility

About

This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.

Enrollment: 204 patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:

  1. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
  2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
  3. sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.

Exclusion criteria

• Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.
• Subject has a history or suspicion of kidney stones.
• Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula
• Subject is receiving strong or moderate CYP3A inhibitors

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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204 participants in 5 patient groups, including a placebo group

RDEA3170 1

Experimental group

Description:

RDEA3170 5mg followed by RDEA3170 7.5mg

Treatment:

Drug: RDEA3170

RDEA3170 2

Experimental group

Description:

RDEA3170 10mg followed by RDEA3170 12.5mg

Treatment:

Drug: RDEA3170

RDEA3170 3

Experimental group

Description:

RDEA3170 12.5mg followed by RDEA3170 15mg

Treatment:

Drug: RDEA3170

RDEA3170 4

Placebo Comparator group

Description:

RDEA3170 Placebo

Treatment:

Drug: Placebo

Allopurinol

Other group

Description:

Allopurinol 200mg

Treatment:

Drug: Allopurinol