Trials Sponsors Conditions Drugs Pricing

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial DiseasePADClaudicationPeripheral Vascular Disease

Outcome Measures

Primary Outcomes (1)

The Present Study is Designed to Explore Two Potential Mechanisms Which Have Been Linked to Dipyridamole Action on the Vessel Wall; Modulation of Vascular Eicosanoid Generation and Prevention of Oxidant Stress.
No analysis could be performed due to the insufficent number of participants enrolled. Data were not collected due to study termination related to the difficulty finding participants that matched the inclusion/exclusion criteria.
Predose and dosing days 30, 90 and 180

Secondary Outcomes (2)

Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Blood Flow Reporting to Added Table.
Predose and dosing days 30, 90 and 180.
Assess the Functional Consequences of Dipyridamole Action, Alone and in Combination With Aspirin Compared With Aspirin Alone on Local Measurements of Flow and Oxygenation. Reporting Blood Oxygenation.
Predose and dosing days 30, 90 and 180.

Study Arms (3)

Dipyridamole 200mg and Aspirin 25mg bid

ACTIVE COMPARATOR

All subjects in this arm will take their assigned medication for 180 days and complete study visits on Day 1(Baseline), 30, 90 and 180. All subjects will bring a 24 hour urine collection and arrive in a fasting state on all visit days for a blood draw after which they will receive breakfast. After assessing vitals, Adverse Event status and medication compliance, they will be escorted to the vascular labs for Doppler Ultrasound and Near Infrared Spectroscopy. (NIRS) of the legs.

Drug: Dipyridamole 200mg and Aspirin 25mg bid:

Dipyridamole 200 mg bid

ACTIVE COMPARATOR

Drug: Dipyridamole 200 mg bid

Interventions

Dipyridamole 200mg and Aspirin 25mg bid:Drug

All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

Also known as: Persantine

Dipyridamole 200mg and Aspirin 25mg bid

Dipyridamole 200 mg bidDrug

All subjects will receive their randomly assigned study medication to be taken each morning and evening approximately 8am and 8 pm for the 180 day duration of the study.

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Grouped treatment entry
Dipyridamole 200mg and Aspirin 25mg bid:
The registry names several treatments. This does not confirm that participants received them together or that they form a single product.
View registry record

Eligibility Criteria

Age18 Years - 79 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Age between 18 - 79
Women of child bearing potential using a medically acceptable method of birth control (oral/transdermal/vaginal hormonal contraception, depo-provera injection, IUD, condom with spermicide, progestin implant, tubal ligation, oophorectomy, TAH) or abstinence.

Sponsors & Collaborators

Boehringer Ingelheim
Industrycollaborator
University of Pennsylvania
Otherlead

Study Sites (3)

Presbyterian Hospital, 51 N. 39th St.

Philadelphia, Pennsylvania, 19104, United States

Translational Research Ctr.,3400 Civic Center Blvd, Building 421, 10th floor, Room 421

Philadelphia, Pennsylvania, 19104, United States

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

MeSH Terms

Conditions

Peripheral Arterial DiseaseIntermittent ClaudicationPeripheral Vascular Diseases

Interventions

DipyridamoleAspirinBID protein, human

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Study encountered difficulty while attempting to find subjects who met all inclusion/exclusion criteria."0" indicated because no analysis was done on samples obtained. Data could not be analyzed due to insufficient number of participants enrolled.

Results Point of Contact

Title: Emile Mohler, MD
Organization: Upenn

Study Officials

Garret A FitzGerald, MD
University of Pennsylvania
PRINCIPAL INVESTIGATOR
Emile R Mohler, MD
University of Pennsylvania
PRINCIPAL INVESTIGATOR
Tilo Grosser, MD
University of Pennsylvania
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

25 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: not applicable
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

May 20, 2009

First Posted

May 21, 2009

Study Start

September 2002

Date type not reported

This date has not been verified as actual or estimated.

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (2)

Study Arms (3)

Dipyridamole 200mg and Aspirin 25mg bid

Dipyridamole 200 mg bid

Interventions

Registry intervention entries

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (3)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Limitations and Caveats

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

Aspirin 25 mg bid

You may not qualify if:

Intervention Hierarchy (Ancestors)

Source record

Locations