---
title: Bleeding Time Study With AZD6482, Clopidogrel and ASA
nct_id: NCT00853450
overall_status: COMPLETED
phase: PHASE1
sponsor: AstraZeneca
study_type: INTERVENTIONAL
primary_condition: Antiplatelet Effect
countries: Sweden
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00853450.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00853450"
ct_last_update_post_date: 2009-08-19
last_seen_at: "2026-05-12T06:04:26.385Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Bleeding Time Study With AZD6482, Clopidogrel and ASA

**Official Title:** A Randomised, Open-label, Single-Centre, Phase I, Crossover Study to Evaluate the Effect of AZD6482, Compared With Clopidogrel, on Bleeding Time in Healthy Volunteers Receiving Low-Dose ASA

**NCT ID:** [NCT00853450](https://clinicaltrials.gov/study/NCT00853450)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 28
- **Lead Sponsor:** AstraZeneca
- **Conditions:** Antiplatelet Effect
- **Start Date:** 2009-02
- **Completion Date:** 2009-07
- **CT.gov Last Update:** 2009-08-19

## Brief Summary

The primary purpose of this study is to evaluate the effect of AZD6482 and clopidogrel on bleeding time when taken together with low-dose ASA.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** MALE
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* BMI between 19.0 and 30.0 kg/m2, inclusive and body weight between 50.0 and 100.0 kg, inclusive
* Provision of written informed consent

Exclusion Criteria:

* Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
* Acute illness, surgical procedure or trauma from 2 weeks before pre-entry visit until the first baseline visit or clinically significant abnormalities in clinical chemistry, haematology, urinalysis or supine BP or pulse
* Known impaired glucose tolerance, known galactose intolerance, total lactase deficiency or glucose-galactose malabsorption or known or suspected Gilbert's syndrome
```

## Arms

- **1** (EXPERIMENTAL) — AZD6482 on top of ASA
- **2** (ACTIVE_COMPARATOR) — Clopidogrel on top of ASA

## Interventions

- **AZD6482** (DRUG) — Single intravenous infusion during a maximum of 5 hours
- **Clopidogrel** (DRUG) — Oral doses given once daily during 7 days. 300 mg on day 1 and 75 mg on day 2 to 7.
- **ASA** (DRUG) — 75 mg orally once daily during 7 days in each treatment arm

## Primary Outcomes

- **Capillary Bleeding Time (CBT)** _(time frame: Prior to first dose in each treatment period, on study day 6 and 7 in treatment period A and on study day 7 in treatment period B)_

## Secondary Outcomes

- **Effect on bleeding** _(time frame: Prior to first dose in each treatment period, twice on study day 6 and three times on study day 7 in treatment period A and twice on study day 7 in treatment period B)_
- **Pharmacokinetics** _(time frame: Prior to AZD6482 infusion and repeatedly during 6 hours after end of infusion)_
- **Safety variables (adverse events, blood pressure, pulse, ECG, safety lab)** _(time frame: Repeatedly during the study)_

## Locations (1)

- Research Site, Lund, Sweden

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.research site|lund||sweden` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00853450.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00853450*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*