Phase IIa Safety and Efficacy Study of SPP635 in Mild to... | NCT00376636

Studies
Phase IIa Safety and Efficacy Study of SPP635 in Mild to Moderate Hypertension

NCT00376636

Sponsor

Speedel Pharma Ltd.

Status

Completed

Last Update Posted

Oct 30, 2007Estimated

Enrollment

35Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

SPP635 (drug)

Countries

Germany

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

Status Module

Record Verification Date

Sep 2006

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

Oct 2006

Primary Completion Date

Not provided

Completion Date

May 2007Actual

First Submitted Date

Sep 14, 2006

First Submission Date that Met QC Criteria

Sep 14, 2006

First Posted Date

Sep 15, 2006Estimated

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

Oct 29, 2007

Last Update Posted Date

Oct 30, 2007Estimated

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

This study is conducted to investigate the effect of the oral renin inhibitor SPP635 on blood pressure in patients with mild to moderate hypertension.

Detailed Description

Renin-Angiotensin system blockade is a well established target for treatment of high blood pressure. Blocking the system at the initial step, however, is a rather new concept that could only be implemented very recently through the availability of novel, oral, renin inhibitors. This study investigates the safety and efficacy of a novel oral renin inhibitor, SPP635.

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

35Actual

Name	Type	Description	Arm Group Labels	Other Names
SPP635 (drug)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lowering of systolic office blood pressure		four weeks
Lowering of diastolic office blood pressure		four weeks

Secondary Outcomes

Measure	Description	Time Frame
Lowering of systolic and diastolic blood pressure (ABPM)		four weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

male or female patients with mild to moderate hypertension

Exclusion Criteria:

female patients of child-bearing potential or breast-feeding

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 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
Sybille Baumann-Noss, MD	IKP Bobenheim GmbH	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
IKP Bobenheim GmbH		Mannheim		68167	Germany

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

Intervention Browse Module

MeSH Terms

ID	Term
D004364	Pharmaceutical Preparations

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided