Safety and Effect of Oral Doses of 5mg or 10mg of SLx-2101 for 14 Days in Patients With Hypertension

NCT ID: NCT00562614

Last Updated: 2023-11-18

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

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-06-30

Study Completion Date

2007-12-31

Brief Summary

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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.

Detailed Description

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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

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

Comparative 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 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 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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Georg Golor, MD

Role: PRINCIPAL_INVESTIGATOR

PAREXEL, Institute for Clinical Pharmacology

Locations

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Parexel, Institute for Clinical Pharmacology

Berlin, , Germany

Site Status

Countries

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Germany

Other Identifiers

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SLx-2101-07-08

Identifier Type: -

Identifier Source: org_study_id

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