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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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014