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

This study has been completed.

First Received: November 20, 2007 Last Updated: December 17, 2008 History of Changes

Sponsored by:	Surface Logix
Information provided by:	Surface Logix
ClinicalTrials.gov Identifier:	NCT00562614

Purpose

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.

Condition	Intervention	Phase
Hypertension	Drug: SLx-2101	Phase II

MedlinePlus related topics: High Blood Pressure

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Crossover Assignment, Safety/Efficacy Study
Official Title:	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 mg or 10 mg Once Daily for up to 14 Days in Patients With Hypertension

Further study details as provided by Surface Logix:

Primary Outcome Measures:

Peripheral systolic, diastolic blood pressures and heart rates [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment:	38
Study Start Date:	June 2007
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental SLx-2101 vs. placebo	Drug: SLx-2101

Detailed Description:

Placebo-corrected supine peripheral systolic, diastolic blood pressures and heart rate
24 hour ambulatory blood pressure and heart rate
Safety and tolerability

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00562614

Locations

Germany
Parexel, Institute for Clinical Pharmacology
Berlin, Germany, D-14050

Sponsors and Collaborators

Surface Logix

Investigators

Principal Investigator:

Georg Golor, MD

PAREXEL, Institute for Clinical Pharmacology

More Information

No publications provided

Responsible Party:	Surface Logix, Inc. ( Warwick Tong, MB, ChB )
Study ID Numbers:	SLx-2101-07-08
Study First Received:	November 20, 2007
Last Updated:	December 17, 2008
ClinicalTrials.gov Identifier:	NCT00562614 History of Changes
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Study placed in the following topic categories:

Vascular Diseases
Hypertension

Additional relevant MeSH terms:

Vascular Diseases
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 06, 2009