EU Clinical Trial Information System (CTIS)

Brand Logo

Brand Logo Light

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

I searched for some studies on AstraZeneca Clinical Trials, and found these studies that may also be of interest to you.
Here is the link to my search results

Official Title

RDEA3170 10mg followed by RDEA3170 12.5mg

RDEA3170 12.5mg followed by RDEA3170 15mg

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.

Phase II Dose Finding Study of RDEA3170 versus Placebo in Japanese Patients with Gout or Asymptomatic Hyperuricemia

NCT ID

Patient Level Data

Therapeutic Area

Research Site

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg versus Placebo and Open-Label Allopurinol 200 mg as a reference arm in Japanese Patients with Gout or Asymptomatic Hyperuricemia

The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.

Age Continuous

Sex: Female, Male

No subject was excluded from the safety and efficacy analysis sets. Some data points of 3 subjects who have incompliance were excluded from the PK analyses due to incorrect dose of RDEA3170

Percent changes of serum uric acid levels from baseline levels

Week 1

Week 2

Week 4

Week 6

Week 8

Week 10

Week 12

Week 16

Week 18

Week 20

Week 24

To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit

Percentage of subjects with a serum uric acid level ≤6.0 mg/dL

To compare percent change in sUA at each study visit.

Percent change in sUA

To compare the absolute change of serum uric acid levels from baseline levels

Absolute change of serum uric acid levels from baseline levels

Overall Study

204 were randomized into one of the following treatment groups; allopurinol, placebo, RDEA3170 Group 1, Group 2 and Group 3.  Of the enrolled subjects, 177 were withdrawn prior to randomization because of ‘eligibility criteria not fulfill’ (176 subjects) or ‘patient decision’ (1 subject).

Fredrik Erlandsson, MD

To compare the proportion of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit

To compare serum uric acid levels at each study visit

To compare percent change of serum uric acid levels from baseline levels

To evaluate the safety and tolerability of RDEA3170 in patients with gout or asymptomatic hyperuricemia

Arms	Assigned Interventions
Experimental: RDEA3170 1 RDEA3170 5mg followed by RDEA3170 7.5mg	Drug: RDEA3170 Oral Treatment
Experimental: RDEA3170 2 RDEA3170 10mg followed by RDEA3170 12.5mg	Drug: RDEA3170 Oral Treatment
Experimental: RDEA3170 3 RDEA3170 12.5mg followed by RDEA3170 15mg	Drug: RDEA3170 Oral Treatment
Placebo Comparator: RDEA3170 4 RDEA3170 Placebo	Drug: Placebo Oral Treatment
Other: Allopurinol Allopurinol 200mg	Drug: Allopurinol Oral Treatment Other Name: Allopurinol 200mg Sawai

Phase II Dose Finding Study of RDEA3170 versus Placebo in Japanese Patients with Gout or Asymptomatic Hyperuricemia

Official Title

Medical condition

Phase

Healthy volunteers

Study drug

Sex

Actual Enrollment

Study type

Age

Date

Study design

Verification:

Sponsors

Collaborators

Inclusion Criteria

Exclusion Criteria

Documents available

Trial Results Summaries

Contacts

Contact