Safety and Effects of SLx-2101 Taken for up to 14 Days on... | NCT00562549

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

NCT00562549

Sponsor

Retension Pharmaceuticals. Inc.

Status

Completed

Last Update Posted

Apr 30, 2026Actual

Enrollment

26Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

SLx-2101

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Official Title

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, 10 or 20 mg Once Daily for up to 14 Days in Patients With Hypertension

Status Module

Record Verification Date

Apr 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2007

Primary Completion Date

Dec 2007Actual

Completion Date

Dec 2007Actual

First Submitted Date

Nov 20, 2007

First Submission Date that Met QC Criteria

Nov 21, 2007

First Posted Date

Nov 22, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 24, 2026

Last Update Posted Date

Apr 30, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

26Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	SLx-2101	Drug: SLx-2101
2	Placebo Comparator	Matching Placebo Dose	Drug: SLx-2101

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SLx-2101	Drug		1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Office seated peripheral systolic and diastolic blood pressure		12 days

Secondary Outcomes

Measure	Description	Time Frame
Adverse events and changes in vital signs		12 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ian B Wilkinson, MD	Addenbrooke's Hospital, Cambridge	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Addenbrooke's Hospital		Cambridge		CB2 2QQ	United Kingdom

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided