Status:
COMPLETED
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Lead Sponsor:
Palatin Technologies, Inc
Conditions:
Hypertension
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
The objective of this study is to evaluate the safety, tolerability, and pharmacokinetics of subcutaneous (SC) PL-3994, relative to placebo in subjects with controlled hypertension. Including in this ...
Detailed Description
Uncontrolled hypertension, including both hypertensive urgency and hypertensive emergency, is commonly seen in emergency rooms and other urgent care settings. Current standards of care include intrave...
Eligibility Criteria
Inclusion
- Subjects must have had a diagnosis of essential hypertension for at least 1 year, per subject verbal history
- Subject must be on a stable dose of at least one, but not more than 3 antihypertensive medications for at least 3 months, per subject verbal history.
- Subject must have a systolic blood pressure at screening between 100 and 150 mmHg, and diastolic blood pressure must not exceed 105 mmHg.
Exclusion
- Subject weight greater than 100 kg or less than 50 kg.
- Any significant medical condition or abnormal safety laboratory results which, in the judgement of the Investigator would place the subject at significant risk.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT00686803
Start Date
April 1 2008
End Date
July 1 2008
Last Update
July 19 2013
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