A Pilot Phase IIa Randomised, Double-blind, Placebo-controlled, Crossover Study to Examine the Safety, Tolerability and Pharmacodynamic Effects on Blood Pressure of Repeat Oral Doses of SLx-2101 5, 10 or 20 mg Once Daily for up to 14 Days in Patients With Hypertension

Response Pharmaceuticals1 site in 1 country26 target enrollmentJuly 2007

ConditionsHypertension

InterventionsSLx-2101

DrugsSLx-2101

Overview

Phase: Phase 2
Intervention: SLx-2101
Conditions: Hypertension
Sponsor: Response Pharmaceuticals
Enrollment: 26
Locations: 1
Primary Endpoint: Office seated peripheral systolic and diastolic blood pressure
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose is to determine the effective dosage and to study the effects of this dosage taken for 12 days on systolic and diastolic blood pressure in patients with hypertension.

Detailed Description

1. Office seated peripheral systolic and diastolic blood pressure 2. Adverse events and vital signs 3. Plasma concentrations of SLx-2101

Registry

clinicaltrials.gov

Start Date

July 2007

End Date

December 2007

Last Updated

3 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Response Pharmaceuticals

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or females between 18 and 80 years, inclusive
•Moderate to severe hypertension
•Body weight within a body mass index range of 18 - 32 kg/m2

Exclusion Criteria

•Subject is receiving more than four antihypertensive agents
•History of drug abuse
•Exposure to a new chemical entity within 3 months prior to the first day of dosing