Safety and Effect of Oral Doses of 5mg or 10mg of SLx-2101 for 14 Days in Patients With Hypertension

Phase 2

Completed

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

• Registration Number: NCT00562614
• Lead Sponsor: Response Pharmaceuticals

Brief Summary

The purpose is to determine the effect of SLx-2101 dosed at 5mg or 10mg for 14 days on systolic, diastolic pressures and heart rate in patients with hypertension.

Detailed Description

1. Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate

2. 24 hour ambulatory blood pressure and heart rate

3. Safety and tolerability

Study Timeline

• Study Start: 2007-06
• Study First Submitted: 2007-11-20
• Study First Submitted QC: 2007-11-20
• Study First Posted: 2007-11-22
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2015-01
• Last Update Submitted: 2023-11-14
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

• Male or female subjects between 18 and 70 years old, inclusive
• Moderate to severe hypertension
• Body weight within a body mass index of 18-32kg/m2

Exclusion Criteria

• The subject is receiving more than three antihypertensive agents
• A 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	Comparative Placebo Dose

Primary Outcome Measures

Name	Time	Method
Peripheral systolic, diastolic blood pressures and heart rates	14 days

Secondary Outcome Measures

Name	Time	Method
Adverse events	14 days

Trial Locations

Locations (1)

Parexel, Institute for Clinical Pharmacology; 🇩🇪 Berlin, Germany