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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:
ClinicalTrials.gov Identifier:
NCT00562614
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 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
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 mg or 10 mg Once Daily for up to 14 Days in Patients With Hypertension

Further study details as provided by Kadmon Corporation, LLC:

Primary Outcome Measures:
  • Peripheral systolic, diastolic blood pressures and heart rates [ Time Frame: 14 days ]

Secondary Outcome Measures:
  • Adverse events [ Time Frame: 14 days ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
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): NCT00562614


Locations
Germany
Parexel, Institute for Clinical Pharmacology
Berlin, Germany, D-14050
Sponsors and Collaborators
Kadmon Corporation, LLC
Investigators
Principal Investigator: Georg Golor, MD PAREXEL, Institute for Clinical Pharmacology
  More Information

Responsible Party: Kadmon Corporation, LLC
ClinicalTrials.gov Identifier: NCT00562614     History of Changes
Other Study ID Numbers: SLx-2101-07-08
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