ARBACE: Effects of Angiotensin Converting Enzyme (ACE) Inhibitors Versus Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01152567

Collaborator

(none)

50,000

Enrollment

Locations

Duration (Months)

892.9

Patients Per Site

177.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The planned Study will be a retrospective study on the effect of ACE's vs. candesartan on cardiovascular events and on health economic effects in a "real life" setting in Sweden.

Condition or Disease	Intervention/Treatment	Phase
Hypertension Cardiovascular Disease

Study Design

Study Type:

Observational

Actual Enrollment :

50000 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Effects of Angiotensin Converting Enzyme Inhibitors vs Candesartan in Reducing Cardiovascular Events in Primary Treatment of Hypertension

Study Start Date :

Jun 1, 2010

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Nov 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
ACE Patients treated for hypertension with ACEs without CVD
Candesartan Patients treated for hypertension with candesartan without CVD

Outcome Measures

Primary Outcome Measures

Investigate the risk of Cardiovascular Disease (CVD) and new onset diabetes in patients on primary hypertensive treatment with ACE or candesartan for hypertension [Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.]

Secondary Outcome Measures

To investigate the risk of CVD and new onset diabetes in patients treated with specific types of ACEi or candesartan for hypertension [Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.]
To investigate the risk of hypertensive organ damage, renal failure and hyperlipidemia for patients treated with ACEi or candesartan [Time to first CV event calculated as the time (in days) between date of index prescription and date of the first registration of a CV event. Patients will be followed for min. 1 wk and up to 9 yrs (1999-2007). Median follow up time is estimated to 2 yrs.]
Evaluate differences in use of health care resources, and assess the potential long term cost effectiveness [Differences in health care consumption will be estimated through models incorporating normalised costs, level of care, age, gender and study year]

Eligibility Criteria

Criteria

Ages Eligible for Study:

17 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

all patients found in electronic patient journals at the participating centres, who were prescribed either ACEis (ATC-C09A-B) or ARBs (C09C-D) for hypertension from 1 January 1999 - 31 December 2007. The first date of such a prescription starts the observation time and is called the index prescription.

Exclusion Criteria:

No history of cardiovascular disease.
Ongoing malignancy

Contacts and Locations

Locations

	Site	City	Country
1	Research Site	Akersberga	Sweden
2	Research Site	Alvdalen	Sweden
3	Research Site	Angelholm	Sweden
4	Research Site	Avesta	Sweden
5	Research Site	Bengtsfors	Sweden
6	Research Site	Borlange	Sweden
7	Research Site	Falun	Sweden
8	Research Site	Farsta	Sweden
9	Research Site	Fritsla	Sweden
10	Research Site	Gagnef	Sweden
11	Research Site	Gavle	Sweden
12	Research Site	Goteborg	Sweden
13	Research Site	Grangesberg	Sweden
14	Research Site	Grycksbo	Sweden
15	Research Site	Hagersten	Sweden
16	Research Site	Hallstahammar	Sweden
17	Research Site	Hasselby	Sweden
18	Research Site	Hedemora	Sweden
19	Research Site	Helsingborg	Sweden
20	Research Site	HenAn	Sweden
21	Research Site	Hollviken	Sweden
22	Research Site	Jarfalla	Sweden
23	Research Site	Kil	Sweden
24	Research Site	Kolback	Sweden
25	Research Site	Kolsva	Sweden
26	Research Site	Koping	Sweden
27	Research Site	Leksand	Sweden
28	Research Site	Lidkoping	Sweden
29	Research Site	Likenas	Sweden
30	Research Site	Limhamn	Sweden
31	Research Site	Ludvika	Sweden
32	Research Site	Malmo	Sweden
33	Research Site	Malung	Sweden
34	Research Site	Mora	Sweden
35	Research Site	Munka-Ljungby	Sweden
36	Research Site	Norberg	Sweden
37	Research Site	Sala	Sweden
38	Research Site	Sater	Sweden
39	Research Site	Skanor	Sweden
40	Research Site	Skepplanda	Sweden
41	Research Site	Skinnskatteberg	Sweden
42	Research Site	Skogas	Sweden
43	Research Site	Skoghall	Sweden
44	Research Site	Skovde	Sweden
45	Research Site	Skultuna	Sweden
46	Research Site	Smedjebacken	Sweden
47	Research Site	Stockholm	Sweden
48	Research Site	Stora Hoga	Sweden
49	Research Site	Sunnansjo	Sweden
50	Research Site	Sunne	Sweden
51	Research Site	Svardsjo	Sweden
52	Research Site	Trollhattan	Sweden
53	Research Site	Upplands Vasby	Sweden
54	Research Site	Uppsala	Sweden
55	Research Site	Vansbro	Sweden
56	Research Site	VasterAs	Sweden