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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00562614

Enrollment

Registered

2007-11-22

Start date

2007-06-01

Completion date

2007-12-01

Last updated

2026-04-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension

Brief summary

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

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

Interventions

DRUGSLx-2101

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 70 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Peripheral systolic, diastolic blood pressures and heart rates	14 days

Secondary

Measure	Time frame
Adverse events	14 days

Countries

Germany

Contacts

PRINCIPAL_INVESTIGATORGeorg Golor, MD

PAREXEL, Institute for Clinical Pharmacology

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 1, 2026