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

NCT ID: NCT00562549

Last Updated: 2023-05-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-07-31

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

SLx-2101

Group Type EXPERIMENTAL

SLx-2101

Intervention Type DRUG

2

Matching Placebo Dose

Group Type PLACEBO_COMPARATOR

SLx-2101

Intervention Type DRUG

Interventions

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SLx-2101

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Response Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ian B Wilkinson, MD

Role: PRINCIPAL_INVESTIGATOR

Addenbrooke's Hospital, Cambridge

Locations

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Addenbrooke's Hospital

Cambridge, , United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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SLx-2101-07-05

Identifier Type: -

Identifier Source: org_study_id

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