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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.
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 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 Blind (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
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

Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT00562614

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

Responsible Party: Kadmon Corporation, LLC Identifier: NCT00562614     History of Changes
Other Study ID Numbers: SLx-2101-07-08
Study First Received: November 20, 2007
Last Updated: January 8, 2015

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases processed this record on August 16, 2017