Atacand (Candesartan) Real Life Study | NCT00620178

Studies
Atacand (Candesartan) Real Life Study

NCT00620178

Sponsor

AstraZeneca

Status

Completed

Last Update Posted

Dec 2, 2010Estimated

Enrollment

14,000Estimated

Phase

Not provided

Conditions

Hypertension

Interventions

Candesartan Cilexetil
Losartan

Countries

Sweden

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

Mar 2008

Primary Completion Date

Feb 2009Actual

Completion Date

Feb 2009Actual

First Submitted Date

Feb 8, 2008

First Submission Date that Met QC Criteria

Feb 8, 2008

First Posted Date

Feb 21, 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 1, 2010

Last Update Posted Date

Dec 2, 2010Estimated

Description Module

Brief Summary

This study is a Swedish historical cohort study in patients prescribed Atacand or Cozaar for hypertension by selected primary care centres. Data will be extracted anonymously from electronic medical records. In addition, data regarding morbidity and mortality will be collected by merging the cohort with the following national registries: the Hospital Discharge Register (Slutenvårdsregistret), the Cause of Death Register and the Heart Intensive Care Admission (RIKS-HIA)

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

14,000Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Candesartan	Drug: Candesartan Cilexetil
2		Losartan	Drug: Losartan

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Candesartan Cilexetil	Drug	oral once daily dose	1	ATACAND

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The primary efficacy objective is to investigate, on basis of 'first to event', the development of new cardiovascular diseases (CVD).		1999 - 2007

Secondary Outcomes

Measure	Description	Time Frame
Cardiovascular disease states and procedures in the background and over the entire observation period will be identified by use of ICD-9 and ICD-10 coding for diseases of the cardiovascular system. Specifically are death, acute cardiovascular events, new		1999 - 2007
Health care consumption will be assessed as contacts with health care providers, in-hospital time periods for cardiovascular disease states with associated therapeutic procedures, and times spent within various levels of care (e.g. ICU and general ward).

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Recorded blood pressure prior to therapy of > 140 and/or 90 mmHg
Diagnosed as hypertensive within 15 months
First prescription of Cozaar or Atacand between 1 January 1999 and 31 December 2007, inclusive

Exclusion Criteria:

Previous prescription within 15 months any drug from the ATC groups C02, C03, C07 - C09 inclusive

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

17 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Eligible subjects are all patients found in EPS systems at the participating centres, who were prescribed candesartan (ATC-C09CA06) or losartan (C09CA01) for hypertension from 1 January 1999 - 31 December 2004 inclusive. The first found prescription is designated as index.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jan Stålhammar, MD	Eriksbergs vårdcentral	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Research Site		Uppsala			Sweden

Condition Browse Module

MeSH Terms

ID	Term
D006973	Hypertension
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C077793	candesartan cilexetil
D019808	Losartan

Ancestor Terms

ID	Term
D001713	Biphenyl Compounds
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided