| Trial ID: | L4962 |
| Source ID: | NCT02786979
|
| Associated Drug: |
Beraprost
|
| Title: |
Efficacy and Safety of Dorner Tablets and Aspirin for Prevention of Arteriosclerosis Progress in Type 2 Diabetes Mellitus Patients
|
| Acronym: |
|
| Status: |
TERMINATED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Type 2 Diabetes Mellitus
|
| Interventions: |
DRUG: Beraprost|DRUG: Aspirin
|
| Outcome Measures: |
Primary: Change from baseline in carotid intima-media thickness, Baseline to Year 3|Incidence and severity of treatment-emergent adverse events, Up to 3 years|Safety assessed by vital signs: body temperature, Up to 3 years|Safety assessed by vital signs: pulse rate, Up to 3 years|Safety assessed by vital signs: respiratory rate, Up to 3 years|Safety assessed by vital signs: blood pressure (systolic blood pressure and diastolic blood pressure), Up to 3 years|Number of participants with abnormal laboratory values and/or adverse events related to treatment, Up to 3 years | Secondary: Death rate, Up to 3 years|Incidence of any vascular event, Vascular events include sudden death, death caused by the vascular event, non-fatal coronary hear disease (CHD), non-fatal cerebrovascular diseases, and non-fatal aorta and peripheral artery disease (PAD), Baseline to Year 3|Change from baseline in Ankle-brachial index, Baseline to Year 3|Change from baseline in Pulse wave velocity, Baseline to Year 3|Change from baseline in Oxidative stress indices, Oxidative stress indices: superoxide dismutase and nitrotyrosine, Baseline to Year 3|Change from baseline in value of VCAM-1, VCMA-1: vascular cell adhesion molecule, Baseline to Year 3|Change from baseline in value of TNF-α, TNF: tumor necrosis factor, Baseline to Year 3
|
| Sponsor/Collaborators: |
Sponsor: Astellas Pharma Inc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
190
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: PREVENTION
|
| Start Date: |
2010-07
|
| Completion Date: |
2013-01
|
| Results First Posted: |
|
| Last Update Posted: |
2016-06-21
|
| Locations: |
Site CN00001, Beijing, Beijing, China|Site CN00002, Beijing, Beijing, China|Site CN00004, Guangzhou, Guangdong, China|Site CN00003, Shanghai, Shanghai, China|Site CN00005, Chengdu, Sichuan, China|Site CN00006, Tianjin, Tianjin, China
|
| URL: |
https://clinicaltrials.gov/show/NCT02786979
|
