A Study to Assess the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics After High Single Ascending Oral Doses of AZD1656 in T2DM Patients
Completed · Phase 1 · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus
In brief
The purpose of this study is to investigate safety and tolerability after high Single Ascending Oral Doses of AZD1656.
Key facts
- Study ID
- NCT01221545
- Run by
- AstraZeneca
- People needed
- 24
- Starts
- 2010-10-01
- Expected to finish
- 2011-01-01
- Last updated by the study team
- 2011-02-17
Who can join
Age: 20 and older, up to 60. Sex: male. Healthy volunteers: not accepted.
You may qualify if…
- Provision of signed and dated, written informed consent prior to any study specific procedures.
- Male, T2DM patients aged 20-60 years
- Treatment with 1 to 2 OADs as Therapy for T2DM for at least 30 days prior to enrollment
- Patients should not have been treated with glitazones within 6 months prior to enrollment
- Male T2DM patients without known cardiovascular disease, with the exception of Grade 1 hypertension without secondary organ involvement (eg. grade 1 HT is allowed if no eye, kidney disease or LVH has been documented).
You may not qualify if…
- History of ischemic heart disease , heart failure, stroke, transitory ischemic attack or peripheral vascular disease.
- Prolonged QTcF>450 msec or shortened QTcF<350 msec or family history of long QT syndrome.
- Any clinically important abnormalities in rhythm, conduction or morphology of resting ECG that may interfere with the interpretation of QTc interval changes.
- Systolic BP>159 mmHg or diastolic BP>99 mmHg at screening and on Day-1
Where it is running
- Research Site — Chula Vista, California, United States
Full record on ClinicalTrials.gov
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