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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 evaluate the efficacy of systemically administered AZD4017, compared with placebo, over a 28-day period in patients with raised intra-ocular pressure (IOP).

A phase IIa study to assess the tolerability, safety, and efficacy of AZD4017 for raised intra-ocular pressure

tablet, oral, one tablet once daily,  28 days

matching placebo tablet, oral, one tablet once daily, 28 days

tablet, oral 2 tablets twice daily, 28 days

matching placebo tablets, oral, 2 tablets twice daily, 28 days

Research Site

A Double Masked, Placebo Controlled, Randomised, Parallel Group Phase IIa Study to assess the Tolerability, Safety, and Efficacy of AZD4017 for Raised Intra-Ocular Pressure

Age Continuous

Age, Customized

Gender, Male/Female

Race/Ethnicity, Customized

Stratification factor

Study Specific Characteristic

Region of Enrollment

Percentage change in mean intra-ocular pressure compared with baseline after 4 weeks treatment

>= 20% decrease in intra-ocular pressure

>= 30% decrease in intra-ocular pressure

Clinically relevant change in intra-ocular pressure after 4 weeks of treatment

Change in mean intra-ocular pressure compared with baseline after 4 weeks treatment

Overall Study

Diagnosis of intra-ocular hypertension (raised IOP), or POAG, with IOP >20 mmHg and =<36 mmHg, and currently prescribed a stable dose of one anti-glaucoma medication that began at least 30 days prior to the screening visit or a diagnosis of intra-ocular hypertension, defined as an IOP >22 mmHg and =<36 mmHg while not on anti-glaucoma medication.

Arms	Assigned Interventions
Experimental: 1) AZD4017 Europe: 200 mg AZD4017	Drug: AZD4017 tablet, oral, one tablet once daily, 28 days
Placebo Comparator: 2) Placebo Europe: placebo	Drug: Placebo matching placebo tablet, oral, one tablet once daily, 28 days
Experimental: 3) AZD4017 USA: 800 mg AZD4017	Drug: AZD4017 tablet, oral 2 tablets twice daily, 28 days
Placebo Comparator: 4) Placebo USA: placebo	Drug: Placebo matching placebo tablets, oral, 2 tablets twice daily, 28 days

A phase IIa study to assess the tolerability, safety, and efficacy of AZD4017 for raised intra-ocular pressure

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

CSR-D4250C00001.pdf

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator