NCT00264706 is a Phase 1/Phase 2 clinical trial of Nona-L-arginine in Saphenous Vein Graft Disease, sponsored by Lumen Therapeutics.

Who is sponsoring NCT00264706?

NCT00264706 is sponsored by Lumen Therapeutics.

What drugs are being tested in NCT00264706?

Interventions in NCT00264706: Nona-L-arginine.

What condition does NCT00264706 study?

NCT00264706 studies Saphenous Vein Graft Disease.

Is NCT00264706 still recruiting?

NCT00264706 is currently terminated. Last updated 7 September 2016.

Last reviewed 2016-09-07 · How we verify

NCT00264706

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

PolyArginine Treated vEiN grafTs (PATENT)

Terminated Phase 1/Phase 2 Last updated 7 September 2016

What this trial tests

Phase 1/Phase 2 trial testing Nona-L-arginine in Saphenous Vein Graft Disease in 25 participants. Terminated before completion.

Timeline

1 March 2005

Primary endpoint
1 April 2008

1 April 2008

Quick facts

Lead sponsor	Lumen Therapeutics
Phase	Phase 1/Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	quadruple
Primary purpose	treatment
Enrollment	25
Start date	1 March 2005
Primary completion	1 April 2008
Estimated completion	1 April 2008
Sites	1 location across Canada

Drugs / interventions tested

Nona-L-arginine — full drug profile →

Conditions studied

Saphenous Vein Graft Disease — all drugs for Saphenous Vein Graft Disease →

Sponsor

Lumen Therapeutics — full company profile →

Who can join

Adults 35 to 85, any sex, with Saphenous Vein Graft Disease. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Safety - as assessed by the nature and frequency of clinical adverse event at 6 weeks post-surgery.
Time frame: 6 weeks
Efficacy - Volume obstruction of the vein grafts measured by IVUS at 1 year.
Time frame: 1 year

Sponsor's own description

The primary objectives of this trial are: 1) to evaluate the safety of NONA-L-ARGININE in ex vivo application to saphenous vein segments prior to grafting; and, 2) to obtain preliminary data on the biological effects of NONA-L-ARGININE, as compared to placebo, in the prevention of neointimal hyperplasia.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00264706 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Lumen Therapeutics
Last refreshed: 7 September 2016

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00264706.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing