Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 12:45 AM
Ignite Modification Date:
2025-12-25 @ 12:45 AM
NCT ID:
NCT01523067
Brief Summary:
The primary objective of the study is to evaluate the safety and tolerability of single ascending doses of Vasomera (PB1046) administered subcutaneously in adult subjects with Stage 1 or Stage 2 essential hypertension.
The secondary objectives of the study are to characterize the pharmacokinetic profile of single ascending doses of Vasomera and the relationship between serum concentrations of Vasomera and change in systolic and diastolic blood pressure as measured by:
* Mean change from baseline in 24-hour systolic and diastolic blood pressure measured by ambulatory blood pressure monitoring (ABPM) as compared to placebo.
* Identification of the minimum and maximum decrease in systolic and diastolic blood pressure as measured by ABPM.
* Mean change from baseline in cuff systolic and diastolic blood pressure as compared to placebo.
* Effect of Vasomera on pulse pressure and heart rate.
An additional secondary objective of this study will be to characterize the immunogenicity profile of Vasomera following a single subcutaneous dose.
Study:
NCT01523067
Study Brief:
Protocol Section:
NCT01523067