Phase 2
Completed N=21
Safety Study of Subcutaneously Administered PL-3994 in Subjects With Controlled Hypertension
Source: ClinicalTrials.gov NCT00686803 ↗Enrolled (actual)
21
Serious AEs
0.0%
Results posted
Jun 2013
Primary outcomePrimary: Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension. — 0; 0.366; 0 ng/mL
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pharmacokinetics of Subcutaneous (SC) PL-3994 Relative to Placebo in Subjects With Controlled Hypertension. |
0; 0.366; 0 | — |
| PRIMARY Pharmacodynamics as Measured by cGMP Levels. |
0.996; 1.435; 0.676 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00686803). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.