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

Response Pharmaceuticals38 enrolled

Overview

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.

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Hypertension

Interventions

SLx-2101DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

Parexel, Institute for Clinical Pharmacology

Berlin, Germany

Outcomes

Primary Outcomes

Peripheral systolic, diastolic blood pressures and heart rates

Time frame: 14 days

Secondary Outcomes

Adverse events

Time frame: 14 days

Data from ClinicalTrials.gov

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