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

This study will compare the impact of including exenatide once weekly in addition to usual care vs. usual care without exenatide on major cardiovascular outcomes as measured by the primary composite endpoint of cardiovascular-related death, nonfatal myocardial infarction (MI), or nonfatal stroke.

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

NCT ID

Therapeutic Area

Subcutaneous injection, 2 mg, administered once weekly.

Subcutaneous injection, matching volume of placebo, administered once weekly.

d5551c00003_bcb109_csp_amendment_6_updated_Redacted

Research Site

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL). A Randomized, Placebo Controlled Clinical Trial to Evaluate Cardiovascular Outcomes after Treatment with Exenatide Once Weekly in Patients with Type 2 Diabetes Mellitus.

Age Continuous

Sex: Female, Male

Race/Ethnicity, Customized

Region of Enrollment

Patient had prior cardiovascular event or not at randomization

Prior CV Event

Study Specific Characteristic

The primary efficacy outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke. The number of participants who had an event is reported in the results.
The primary efficacy endpoint is the same as the primary safety endpoint, and the statistical analysis tests the superiority of exenatide against the placebo.

ITT population: all patients consented and randomized in the study without a major GCP violation. ITT population is analyzed as randomized.

Primary Efficacy Outcome MACE Events

The primary safety outcome variable is defined as the composite endpoint of cardiovascular death, nonfatal MI, or nonfatal stroke.  The number of participants who had an event is reported in the results.
The primary safety endpoint is the same as the primary efficacy endpoints, and the statistical analysis tests the non-inferiority of exenatide against placebo.

This analysis uses the same endpoint and cox regression method as the primary efficacy analysis. However, the statistical hypothesis is a non-inferiority test with a margin of HR=1.3.

Primary Safety Outcome MACE Events

The secondary efficacy outcome variable is defined as the all-cause mortality (deaths).  The number of participants who had an event is reported in the results.

Secondary Efficacy Outcome All-Cause Mortality

Component of the primary efficacy outcome: cardiovascular death. The number of participants who had an event is reported in the results.

Secondary Efficacy Outcome CV Death

Component of primary efficacy outcome: fatal or non-fatal MI. The number of participants who had an event is reported in the results.

Secondary Efficacy Outcome MI

Component of primary efficacy outcome: fatal or non-fatal stroke.  The number of participants who had an event is reported in the results.

Secondary Efficacy Outcome Stroke

The secondary efficacy outcome variable is defined as hospitalization for acute coronary syndrome.  The number of participants who had an event is reported in the results.

Secondary Efficacy Outcome Hospitalization for ACS

The secondary efficacy outcome variable is defined as hospitalization for heart failure.  The number of participants who had an event is reported in the results.

Arms	Assigned Interventions
Experimental: Exenatide Once Weekly	Drug: Exenatide Once Weekly Subcutaneous injection, 2 mg, administered once weekly.
Placebo Comparator: Placebo	Drug: Placebo Subcutaneous injection, matching volume of placebo, administered once weekly.

Exenatide Study of Cardiovascular Event Lowering Trial (EXSCEL): A Trial To Evaluate Cardiovascular Outcomes After Treatment With Exenatide Once Weekly In Patients With Type 2 Diabetes Mellitus

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

d5551c00003_bcb109_csp_amendment_6_updated_Redacted

d5551c00003 SAP Redacted

d5551c00003 CSP Redacted

Trial Results Summaries

Contacts

Contact

Investigators

Principal Investigator