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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.
Sponsor:
Information provided by:
Surface Logix
ClinicalTrials.gov Identifier:
NCT00562614
First received: November 20, 2007
Last updated: December 17, 2008
Last verified: October 2007
History of Changes
  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 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

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
Experimental: 1
SLx-2101 vs. placebo
 Drug: SLx-2101

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

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013