A Long Term Study of SPP100 in Patients With Essential Hy... | NCT00246584

Studies
A Long Term Study of SPP100 in Patients With Essential Hypertension (Trial is Not Recruiting in the US)

NCT00246584

Sponsor

Novartis

Status

Completed

Last Update Posted

Jul 28, 2006Estimated

Enrollment

300

Phase

Phase 2

Conditions

Hypertension

Interventions

SPP100

Countries

Switzerland

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

Jul 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 2004

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 27, 2005

First Submission Date that Met QC Criteria

Oct 28, 2005

First Posted Date

Oct 31, 2005Estimated

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

Jul 27, 2006

Last Update Posted Date

Jul 28, 2006Estimated

Description Module

Brief Summary

This study will evaluate the safety and efficacy of long term treatment of SPP100 in patients with essential hypertension. (Trial is not recruiting in the US)

Detailed Description

Not provided

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

300

Name	Type	Description	Arm Group Labels	Other Names
SPP100	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of adverse events, vital signs, abnormal laboratory changes,etc.

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in diastolic blood pressure after 52 weeks
Change from baseline in systolic blood pressure after 52 weeks
Diastolic blood pressure < 90 mmHg or a reduction of > 10 mmHg after 52 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnosed as essential hypertension -

Exclusion Criteria:

Patients with secondary hypertension or suspected of having secondary hypertension.
Patients suspected of having malignant hypertension
Patients with any serious diseases or symptoms

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 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
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		Basel			Switzerland

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