NCT00725881

Brief Summary

The purpose of this study is to evaluate the safety and pharmacokinetics of multiple, once-daily, intravenous doses of trans sodium crocetinate (TSC). The effectiveness of TSC in alleviating the symptoms of intermittent claudication (IC) will also be assessed.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Aug 2008

Geographic Reach
1 country

7 active sites

Status
completed

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

First Submitted

Initial submission to the registry

July 29, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

July 29, 2011

Status Verified

July 1, 2011

Enrollment Period

1.6 years

First QC Date

July 29, 2008

Last Update Submit

July 1, 2011

Conditions

Intermittent Claudication

Keywords

PADPeripheral arterial diseasePeripheral artery diseaseIntermittent claudicationICatherosclerosisleg painwalking pain

Outcome Measures

Primary Outcomes (1)

  • Safety (laboratory tests, vital signs, ECG, physical exam, pulse oximetry) and pharmacokinetic assessments

    Screening, Baseline, Dose 1, Dose 2, Dose 3, Dose 4, Dose 5, 5-Day Follow-up, 14-Day Follow-up

Secondary Outcomes (1)

  • Change in peak walking time (PWT) and claudication onset time (COT) in an exercise treadmill test

    Baseline, Dose 1, Dose 5, 5-Day Follow-up

Study Arms (9)

1

EXPERIMENTAL

.25 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

2

EXPERIMENTAL

.5 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

3

EXPERIMENTAL

.75 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

4

EXPERIMENTAL

1.0 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

5

EXPERIMENTAL

1.25 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

6

EXPERIMENTAL

1.5 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

7

EXPERIMENTAL

1.75 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

8

EXPERIMENTAL

2.0 mg/kg TSC

Drug: Trans sodium crocetinate (TSC)

9

PLACEBO COMPARATOR

5.0 mL 0.9% normal saline

Drug: 0.9% normal saline

Interventions

Trans sodium crocetinate (TSC)DRUG

Once-daily bolus intravenous injections in a superficial vein of the arm via syringe over a period of up to 2 minutes. Each patient will receive up to 5 doses given on 5 consecutive days

12345678
0.9% normal salineDRUG

A total volume of 5.0 mL normal saline will be dosed in a superficial vein of the arm via syringe over a period of up to 2 minutes.

9

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Aged 40 or older, male or female
  • mo. history of walking limitation or symptoms of intermittent claudication (IC) in at least 1 lower limb, severity of which has not changed in the past 3 mo. and diagnosed by principal investigator as clinically stable Fontaine Stage II peripheral artery disease (PAD)
  • Diagnosis of PAD secondary to atherosclerosis
  • If ankle-brachial index (ABI) is \> 1.3 or cannot be measured in either leg, vascular etiology documented by toe-brachial index (TBI) ≤ 0.7 in at least 1 leg
  • Claudication severity, meds. for the treatment of coronary artery disease (CAD), PAD and IC, and exercise habits should be clinically stable for 3 mo. prior to Screening (SCRN) and during study. Pt. is not likely to change smoking and/or exercise habits during study
  • On an exercise treadmill test (ETT), peak walking time (PWT) of at least 1 min., but no more than 12 min. at Baseline
  • Willing and able to discontinue Pletal or Trental for 21 days before SCRN and during study
  • Antihypertensive therapy, cholesterol-lowering therapy, chronic oral nitrates, and diabetic therapy have been stable for 30 days prior to SCRN
  • Willing and able to provide written, signed, informed consent after the nature of the study has been explained and prior to any research-related procedures
  • Willing and able to comply with all study-related procedures
  • Sexually active patients must use an acceptable method of contraception while participating in the study
  • Females of childbearing potential must have a negative pregnancy test at SCRN and have additional pregnancy tests during the study

You may not qualify if:

  • Pregnant or lactating
  • Current or history of critical limb ischemia (CLI)
  • Pts. in whom artery insufficiency in the lower extremity is the result of acute limb ischemia (ALI) or an immunological or inflammatory non-atherosclerotic disorder
  • Pts. in whom walking impairment due to pain is the result of other non-atherosclerotic co-morbid conditions
  • A surgical intervention to alleviate symptoms of IC or PAD-specific endovascular intervention or cardiovascular surgery within 3 mo. of SCRN
  • Walking limited by reasons other than claudication
  • Conditions other than IC of significant severity that could confound PWT on the ETT
  • Concurrent severe congestive heart failure (CHF)
  • Life-threatening ventricular arrhythmias, unstable angina, and/or myocardial infarction (MI) within 3 mo. before enrollment (ENRL)
  • Coronary artery bypass grafting or percutaneous coronary intervention within 4 mo. before ENRL
  • Renal and/or carotid revascularization procedure within 3 mo. of ENRL
  • Transient ischemic attack (TIA) within 3 mo. before ENRL
  • Deep vein thrombosis (DVT) within 3 mo. before ENRL
  • Severe chronic obstructive pulmonary disease (COPD)
  • Thrombocytopenia
  • +17 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Cardiology, P.C.

Birmingham, Alabama, 35211, United States

Location

Radiant Research, Inc.

Santa Rosa, California, 95405, United States

Location

Stanford University School of Medicine, Division of Cardiovascular Medicine

Stanford, California, 94305-5406, United States

Location

Andrews Research and Education

Pensacola, Florida, 32561, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Clinical Trials of Texas, Inc.

San Antonio, Texas, 78229, United States

Location

Related Publications (1)

  • Mohler ER 3rd, Gainer JL, Whitten K, Eraso LH, Thanaporn PK, Bauer T. Evaluation of trans sodium crocetinate on safety and exercise performance in patients with peripheral artery disease and intermittent claudication. Vasc Med. 2011 Oct;16(5):346-53. doi: 10.1177/1358863X11422742.

    PMID: 22003000DERIVED

MeSH Terms

Conditions

Intermittent ClaudicationPeripheral Arterial DiseaseAtherosclerosis

Interventions

trans-sodium crocetinateSaline Solution

Condition Hierarchy (Ancestors)

Peripheral Vascular DiseasesVascular DiseasesCardiovascular DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsArteriosclerosisArterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 29, 2008

First Posted

July 31, 2008

Study Start

August 1, 2008

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

July 29, 2011

Record last verified: 2011-07

Locations

US(7)