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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00160160
Other study ID # S171.3.012
Secondary ID 2004-00703-18
Status Completed
Phase N/A
First received September 8, 2005
Last updated January 29, 2009
Start date October 2004

Study information

Verified date January 2009
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

This study is to demonstrate the superiority of combination of eprosartan/HCTZ versus ramipril/HCTZ.


Recruitment information / eligibility

Status Completed
Enrollment 440
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility Inclusion Criteria:

- essential hypertension,

- diabetes type 2

Exclusion Criteria:

- severe cardiovascular disease,

- grade 3 hypertension,

- secondary hypertension,

- abnormal liver enzymes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
eprosartan/HCTZ


Locations

Country Name City State
Canada Site 26 Calgary
Canada Site 27 Montreal
Canada Site 30 Quebec
Canada Site 31 Thornhill
Canada Site 28 Vancouver
Canada Site 29 Winnipeg
Denmark Site 39 Holbaek
Denmark Site 38 Roskilde
Denmark Site 40 Viborg
France Site 4 Anzin
France Site 3 Blois
France Site 10 Chemellier
France Site 11 Cholet
France Site 15 Cholet
France Site 16 Cholet
France Site 14 La Jubaudiere
France Site 13 Le Mesnil-en-Vallee
France Site 7 Murs-Erigne
France Site 9 Saumur
France Site 8 Segre
France Site 12 St Pierre Montlim
France Site 6 Thouars
France Site 2 Tours
France Site 5 Vieux Conde
Germany Site 20 Bad Muenster
Germany Site 22 Floersheim
Germany Site 19 Kirweiler
Germany Site 21 Lambrecht
Germany Site 25 Lindau
Germany Site 18 Lueneburg
Germany Site 24 Lutherstadt
Germany Site 17 Riesa
Germany Site 23 Waldbrunn
Italy Site 62 Bologna
Italy Site 60 Napoli
Italy Site 58 Padova
Italy Site 59 Palermo
Italy Site 63 Pavia
Italy Site 61 Pisa
Italy Site 64 Torino
Norway Site 43 Alesund
Norway Site 42 Bergen
Norway Site 44 Horten
Norway Site 41 Skedsmokorset
Spain Site 55 Badajoz
Spain Site 51 Badalona
Spain Site 56 Barcelona
Spain Site 57 Barcelona
Spain Site 54 Ciudad Real
Spain Site 53 Granada
Spain Site 52 Madrid
Sweden Site 48 Angelholm
Sweden Site 47 Goteburg
Sweden Site 46 Helsingborg
Sweden Site 45 Kristianstat
Sweden Site 50 Malmo
Sweden Site 49 Stockholm
United Kingdom Site 33 Aberdeen
United Kingdom Site 36 Bath
United Kingdom Site 37 Liverpool
United Kingdom Site 34 Manchester
United Kingdom Site 32 Oldham
United Kingdom Site 35 Rugby

Sponsors (1)

Lead Sponsor Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Canada,  Denmark,  France,  Germany,  Italy,  Norway,  Spain,  Sweden,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Blood pressure reduction
Secondary Comparison of responder rates
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