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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.
Information provided by (Responsible Party):
Kadmon Corporation, LLC Identifier:
First received: November 20, 2007
Last updated: January 8, 2015
Last verified: January 2015
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
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

Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00562549

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

Responsible Party: Kadmon Corporation, LLC Identifier: NCT00562549     History of Changes
Other Study ID Numbers: SLx-2101-07-05
Study First Received: November 20, 2007
Last Updated: January 8, 2015

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on September 21, 2017