NCT02786979

Brief Summary

The objective was to evaluate the efficacy and safety of combination of beraprost and aspirin for prevention of arteriosclerosis progress in type 2 diabetes mellitus patients.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
190

participants targeted

Target at P50-P75 for phase_4 type-2-diabetes-mellitus

Timeline
Completed

Started Jul 2010

Typical duration for phase_4 type-2-diabetes-mellitus

Geographic Reach
1 country

6 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2016

Completed
Last Updated

June 21, 2016

Status Verified

May 1, 2016

Enrollment Period

2.5 years

First QC Date

May 26, 2016

Last Update Submit

June 17, 2016

Conditions

Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes MellitusArteriosclerosisberaprostAspirin

Outcome Measures

Primary Outcomes (7)

  • 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 Outcomes (7)

  • Death rate

    Up to 3 years

  • Incidence of any vascular event

    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

    Baseline to Year 3

  • +2 more secondary outcomes

Study Arms (2)

Beraprost sodium tablet and Aspirin combination group

EXPERIMENTAL

Oral

Drug: BeraprostDrug: Aspirin

Aspirin Group

EXPERIMENTAL

Oral

Drug: Aspirin

Interventions

BeraprostDRUG

Oral

Also known as: Dorner (R)
Beraprost sodium tablet and Aspirin combination group
AspirinDRUG

Oral

Aspirin GroupBeraprost sodium tablet and Aspirin combination group

Eligibility Criteria

Age50 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients diagnosed as type 2 diabetes mellitus;
  • Patients who had the intima-media thickness (IMT) of carotid artery ≥1.1 mm in at least one side;
  • Patients who had results of aspartate aminotransferase, alanine aminotransferase, and serum creatinine no more than 1.5 times higher than the upper limit of normal;
  • Patients who had not cardio or cerebral vascular events within 3 months, including non-fatal myocardial infarction, stable and unstable angina pectoris, and non-fatal cerebral ischemic and hemorrhagic stroke;
  • Patients who had their systolic blood pressure \<160 mmHg, diastolic blood pressure \<100 mmHg, and glycated hemoglobin (HbA1c) \<8.0%;
  • Patients who had not taken any medications with antithrombotic and antiplatelet effect within 3 months;

You may not qualify if:

  • Patients who had peptic ulcer or active alimentary tract hemorrhage;
  • Patients who had a known allergy to prostacycline or non-steroid medications;
  • Patients who were pregnant, breast feeding, or had planned to be pregnant;
  • Patients who were attending or had attended any clinical studies within 3 months;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Site CN00001

Beijing, Beijing Municipality, China

Location

Site CN00002

Beijing, Beijing Municipality, China

Location

Site CN00004

Guangzhou, Guangdong, China

Location

Site CN00003

Shanghai, Shanghai Municipality, China

Location

Site CN00005

Chengdu, Sichuan, China

Location

Site CN00006

Tianjin, Tianjin Municipality, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Arteriosclerosis

Interventions

beraprostAspirin

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Medical Director

    Astellas Pharma Inc

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 1, 2016

Study Start

July 1, 2010

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

June 21, 2016

Record last verified: 2016-05

Locations

CN(6)