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

April 28, 2023 updated by: Response Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
      • Cambridge, United Kingdom, CB2 2QQ
        • Addenbrooke's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
SLx-2101
Drug: SLx-2101
Placebo Comparator: 2
Matching Placebo Dose
Drug: SLx-2101

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Office seated peripheral systolic and diastolic blood pressure
Time Frame: 12 days
12 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events and changes in vital signs
Time Frame: 12 days
12 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Response Pharmaceuticals

Investigators

  • Principal Investigator: Ian B Wilkinson, MD, Addenbrooke's Hospital, Cambridge

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 20, 2007

First Submitted That Met QC Criteria

November 21, 2007

First Posted (Estimate)

November 22, 2007

Study Record Updates

Last Update Posted (Actual)

May 3, 2023

Last Update Submitted That Met QC Criteria

April 28, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SLx-2101-07-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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