NCT00562614

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for phase_2 hypertension

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_2 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 20, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 22, 2007

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

April 30, 2026

Status Verified

April 1, 2026

Enrollment Period

6 months

First QC Date

November 20, 2007

Last Update Submit

April 24, 2026

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • Peripheral systolic, diastolic blood pressures and heart rates

    14 days

Secondary Outcomes (1)

  • Adverse events

    14 days

Study Arms (2)

1

EXPERIMENTAL

SLx-2101

Drug: SLx-2101

2

PLACEBO COMPARATOR

Comparative Placebo Dose

Drug: SLx-2101

Interventions

SLx-2101DRUG
12

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Parexel, Institute for Clinical Pharmacology

Berlin, D-14050, Germany

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Georg Golor, MD

    PAREXEL, Institute for Clinical Pharmacology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 20, 2007

First Posted

November 22, 2007

Study Start

June 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

April 30, 2026

Record last verified: 2026-04

Locations

DE(1)