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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

Explorative study in Atrial Fibrillation patients to assess Safety and Pharmacokinetics at initiation of treatment and at steady state

Explorative study of AZD1305 in Atrial Fibrillation patients

AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2

AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2

Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2

Research Site

A Randomised, Placebo-controlled, Double-blind, Parallel-group, Multicentre, Phase IIa Study to Explore the Relationship between QTcF Interval at First Dose (Loading Dose) and at Steady State after Treatment with AZD1305 Extended-release Tablets or Placebo when given to Patients with Documented AF

Maximum of all QTcF values obtained for any given patient from randomisation until the intended end of the study drug period, day 10.

Age Continuous

Gender, Male/Female

Maximum QTcF

Number of patients who had at least one AE according to the definition in the study protocol

Adverse Events (AE)

Population PK model parameter estimates derived from plasma concentrations of AZD1305

Estimated Cmax (Maximum Plasma Concentration) (PK modeling) at Steady-state

Percentage of twice daily TTM recordings (individual compliance) transmitted and available for analysis

Compliance with Trans Telephonic Monitoring (TTM)

Overall Study

All patients will attend a pre-entry Visit 3-28 days before the planned randomisation. At this Visit, the Investigator ensures that a signed Informed Consent Form has been obtained before any study specific procedures are conducted. Patients who have given their consent to participate in the study will then undergo a full clinical assessment

Arms	Assigned Interventions
Experimental: AZD1305 loading dose 250 mg + 125 mg Tablets	Drug: AZD1305 AZD1305 loading dose 250 mg + 125 mg evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
Experimental: AZD1305 loading dose 500 mg + placebo Tablets	Drug: AZD1305 AZD1305 loading dose 500 mg + placebo evening dose on Study Day 1, maintenance dose 125 mg twice daily from Study Day 2
Placebo Comparator: Placebo corresponding to AZD1305 loading dose Tablets	Drug: Placebo Placebo corresponding to AZD1305 loading dose + evening dose on Study Day 1, maintenance dose twice daily from Study Day 2

Explorative study of AZD1305 in Atrial Fibrillation 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=314&filename=CSR-D3190C00019.pdf

CSR-D3190C00019.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator