In-practice Evaluation of Atacand 16mg Antihypertensive E... | NCT00802542

Studies
In-practice Evaluation of Atacand 16mg Antihypertensive Effect

NCT00802542

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 3, 2010Estimated

Enrollment

400Estimated

Phase

Not provided

Conditions

Essential Hypertension

Interventions

Not provided

Countries

Latvia

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

Dec 2010

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

Nov 2008

Primary Completion Date

Jan 2009Actual

Completion Date

Jan 2009Actual

First Submitted Date

Dec 4, 2008

First Submission Date that Met QC Criteria

Dec 4, 2008

First Posted Date

Dec 5, 2008Estimated

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

Dec 2, 2010

Last Update Posted Date

Dec 3, 2010Estimated

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 of this study is to prove in practice the effectiveness of Atacand 16 mg in reducing blood pressure after 4 weeks of administration and the importance of administration of adequate doses

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

400Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Adult patients with mild or moderate essential hypertension who do not tolerate ACE inhibitors because of cough, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal and the doctor has decided to increase the Atacand dose to 16mg as per SmPC.

Interventions

Not provided

Measure	Description	Time Frame
Decrease in blood pressure		once after 4 weeks

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Adult patients with mild (140-159/90-99 mgHg) to moderate (160-179/100-109 mmHg) essential hypertension, already treated with Atacand 8mg for 2-4 weeks, who have not reached the blood pressure treatment goal at least <140/90 mgHg and the doctor has decided
Signed and dated Patient Informed Consent (ICF)

Exclusion Criteria:

Hypersensitivity to the active substance or to any of the excipients of Atacand.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

out-patient departments

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Agrita Hartmane	AstraZeneca	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research site		Daugavpils			Latvia
Research site

Condition Browse Module

MeSH Terms

ID	Term
D000075222	Essential Hypertension
D006973	Hypertension

Ancestor Terms

ID	Term
D014652	Vascular Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided