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

This study has been completed.
Sponsor:
Information provided by:
Surface Logix
ClinicalTrials.gov Identifier:
NCT00562549
First received: November 20, 2007
Last updated: December 17, 2008
Last verified: October 2007
History of Changes
  Purpose

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.


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, 10 or 20 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:
  • Office seated peripheral systolic and diastolic blood pressure [ Time Frame: 12 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Adverse events and changes in vital signs [ Time Frame: 12 days ] [ Designated as safety issue: Yes ]

Enrollment: 26
Study Start Date: July 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 or matching placebo
 Drug: SLx-2101

Detailed Description:
  1. Office seated peripheral systolic and diastolic blood pressure
  2. Adverse events and vital signs
  3. Plasma concentrations of SLx-2101
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00562549

Locations
United Kingdom
Addenbrooke's Hospital
Cambridge, United Kingdom, CB2 2QQ
Sponsors and Collaborators
Surface Logix
Investigators
Principal Investigator: Ian B Wilkinson, MD Addenbrooke's Hospital, Cambridge
  More Information

No publications provided

Responsible Party: Warwick Tong, MB, ChB, Surface Logix, Inc.
ClinicalTrials.gov Identifier: NCT00562549     History of Changes
Other Study ID Numbers: SLx-2101-07-05
Study First Received: November 20, 2007
Last Updated: December 17, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013