Safety and Effects of SLx-2101 Taken for up to 14 Days on Blood Pressure in Patients With Hypertension

Phase 2

Completed

• Conditions: Hypertension
• Interventions: Drug: SLx-2101

• Registration Number: NCT00562549
• Lead Sponsor: Response Pharmaceuticals

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

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-21
• Study First Posted: 2007-11-22
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-28
• Last Update Posted: 2023-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1	SLx-2101	SLx-2101
2	SLx-2101	Matching Placebo Dose

Primary Outcome Measures

Name	Time	Method
Office seated peripheral systolic and diastolic blood pressure	12 days

Secondary Outcome Measures

Name	Time	Method
Adverse events and changes in vital signs	12 days

Trial Locations

Locations (1)

Addenbrooke's Hospital; 🇬🇧 Cambridge, United Kingdom