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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:
ClinicalTrials.gov Identifier:
NCT00562549
First Posted: November 22, 2007
Last Update Posted: January 12, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Kadmon Corporation, LLC
  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
Intervention Model: Crossover Assignment
Masking: Double (Participant, 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

Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:
  • Office seated peripheral systolic and diastolic blood pressure [ Time Frame: 12 days ]

Secondary Outcome Measures:
  • Adverse events and changes in vital signs [ Time Frame: 12 days ]

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
Drug: SLx-2101
Placebo Comparator: 2
Matching Placebo Dose
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00562549


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

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT00562549     History of Changes
Other Study ID Numbers: SLx-2101-07-05
First Submitted: November 20, 2007
First Posted: November 22, 2007
Last Update Posted: January 12, 2015
Last Verified: January 2015

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases