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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Palatin Technologies
ClinicalTrials.gov Identifier:
NCT00686803
First received: May 27, 2008
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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 Intervention Phase
Hypertension
Drug: PL3994
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Palatin Technologies:

Primary Outcome Measures:
  • Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    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.


  • Pharmacodynamics as Measured by cGMP Levels. [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

    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.



Enrollment: 21
Study Start Date: April 2008
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686803

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

No publications provided

Responsible Party: Palatin Technologies
ClinicalTrials.gov Identifier: NCT00686803     History of Changes
Other Study ID Numbers: PL3994-003
Study First Received: May 27, 2008
Results First Received: August 24, 2011
Last Updated: July 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Palatin Technologies:
hypertension
controlled hypertension
hypertensives

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on October 01, 2014