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Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension

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ClinicalTrials.gov Identifier: NCT00686803
Recruitment Status : Completed
First Posted : May 30, 2008
Results First Posted : June 21, 2013
Last Update Posted : July 19, 2013
Sponsor:
Information provided by (Responsible Party):
Palatin Technologies

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 evaluation is the effect PL3994 has on blood pressure.

Condition or disease Intervention/treatment Phase
Hypertension Drug: PL3994 Drug: Placebo Phase 2

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 intravenously administered drugs, which can be difficult to titrate and require ongoing monitoring. This study examines the effect of PL-3994 on patients with controlled hypertension who are receiving antihypertensive medications.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Single-Center, Single-Dose, Placebo-Controlled, Randomized, Double-Blind, Ascending Dose Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Study Start Date : April 2008
Actual Primary Completion Date : July 2008
Actual Study Completion Date : July 2008

Arm Intervention/treatment
Experimental: PL3994 Dose A
PL3994 Dose A
Drug: PL3994
Study drug
Experimental: PL3994 Dose B
PL3994 Dose B
Drug: PL3994
Study drug
Experimental: PL3994 Dose C
PL3994 Dose C
Drug: PL3994
Study drug
Experimental: PL3994 Dose D
PL3994 Dose D
Drug: PL3994
Study drug
Experimental: PL3994 Dose E
PL3994 Dose E
Drug: PL3994
Study drug
Placebo Comparator: Placebo
Placebo
Drug: Placebo
Placebo



Primary Outcome Measures :
  1. Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension. [ Time Frame: 24 hours ]

    The pharmacokinetic profile parameters for PL-3994 were calculated using a non compartmental approach.

    •Maximum concentration (Cmax)

    The subject numbers below are the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PK parameters were possible.


  2. Pharmacodynamics as Measured by cGMP Levels. [ Time Frame: 24 hours ]

    Pharmacodynamic parameters were calculated from the baseline-adjusted plasma cGMP level-time data using WinNonlin® 5.0.1. Actual sample times were used in the calculations. Baseline was the pre-dose levels of plasma cGMP at Visit 2 (Day 1): Emax

    The patient numbers below represent the evaluable subjects only. The Evaluable Subjects population consisted of subjects who received study drug and who had no major protocol deviations that would have excluded the subject from analysis, and for whom calculations of PD parameters were possible.




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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686803


Sponsors and Collaborators
Palatin Technologies
Investigators
Study Director: Steven Fischkoff, MD Palatin Technologies
Study Director: Robert Jordan Palatin Technologies

Responsible Party: Palatin Technologies
ClinicalTrials.gov Identifier: NCT00686803     History of Changes
Other Study ID Numbers: PL3994-003
First Posted: May 30, 2008    Key Record Dates
Results First Posted: June 21, 2013
Last Update Posted: July 19, 2013
Last Verified: July 2013

Keywords provided by Palatin Technologies:
hypertension
controlled hypertension
hypertensives

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases