SPP100 Dose Finding Study in Japan | NCT00311012

Studies
SPP100 Dose Finding Study in Japan

NCT00311012

Sponsor

Novartis

Status

Completed

Last Update Posted

Nov 8, 2011Estimated

Enrollment

445Actual

Phase

Phase 2

Conditions

Hypertension

Interventions

Aliskiren

Countries

Japan

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

Jun 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

Aug 2004

Primary Completion Date

Mar 2005Actual

Completion Date

Mar 2005Actual

First Submitted Date

Mar 31, 2006

First Submission Date that Met QC Criteria

Apr 4, 2006

First Posted Date

Apr 5, 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

Nov 7, 2011

Last Update Posted Date

Nov 8, 2011Estimated

Description Module

Brief Summary

This study will evaluate the efficacy of SPP100 in lowering blood pressure in patients with essential hypertension.

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

445Actual

Name	Type	Description	Arm Group Labels	Other Names
Aliskiren	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change from baseline in mean sitting diastolic blood pressure after 8 weeks

Secondary Outcomes

Measure	Description	Time Frame
Change from baseline in mean sitting systolic blood pressure after 8 weeks
Diastolic blood pressure less than 90 mmHg or 10 mmHg or greater change from baseline after 8 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Mild to moderate essential hypertension
Age: ≥20 years old and <80 years old (at time informed consent obtained)
Sex: N/A
Admission status: Outpatient

Exclusion Criteria:

Pregnant women, lactating women, potentially pregnant women, or women who wish to become pregnant
Patients having a mean sitting diastolic blood pressure of ≥110 mmHg and/or a mean sitting systolic blood pressure of ≥180 mmHg at either Visit 2 or 3
Patients with secondary hypertension as a complication or patients suspected of having secondary hypertension(due to aortic coarctation, primary aldosteronism, coarctation of renal artery, renal hypertension
Patients suspected of having malignant hypertension

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, Japan	Novartis Pharmaceuticals, Japan	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novartis Pharmaceuticals		Tokyo			Japan

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
C446481	aliskiren

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided