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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.

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Official Title

The purpose of this study is to assess the tolerability (effect of drug on body) and pharmacokinetics (effect of body on drug) of AZD9668 in patients with mild to moderate COPD

A two week study to assess the tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) patients

30mg oral tablets twice daily (bid) for 14 days

Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

Research Site

A 2-week, randomized, double-blind, placebo-controlled, parallel group study to assess the tolerability and pharmacokinetics of orally administered AZD9668 in patients with COPD

ALT level greater than 3 times the upper limit of normal

AST level greater than 3 times the upper limit of normal

Creatinine level greater than the upper limit of normal

QTcF change from baseline greater than 60 ms

Age Continuous

Gender, Male/Female

Alanine aminotransferase (ALT)

Aspartate aminotransferase (AST)

Creatine kinase (CK)

Total bilirubin

Creatinine

Haemoglobin (Hb)

Reticulocytes

Leucocytes

QTcF (QT interval corrected for heart rate by Fridericia’s method)

QTcF

Change from baseline to Day 14 in absolute neutrophil count

Sputum absolute neutrophil count

Change from baseline to Day 14 in percentage neutrophil count

Sputum differential neutrophil count

AZD9668 sputum concentrations

Number of patients with an increase in bacteriological count from Day -1 to Day 15

Arms	Assigned Interventions
Experimental: 1 Active Treatment	Drug: AZD9668 30mg oral tablets twice daily (bid) for 14 days
Placebo Comparator: 2 Placebo Treatment	Drug: Placebo Matched placebo to 30mg oral tablet twice daily (bid) for 14 days

A two week study to assess the tolerability of AZD9668 in Chronic Obstructive Pulmonary Disease (COPD) patients

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

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=231&filename=CSP-D0520C00002.pdf

CSP-D0520C00002.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator