Clinical trial NCT00160160: Comparison of Eprosartan/HCT Versus Enalapril/HCT in Hypertensives With Type II Diabetes
Official title: A Multi-Center, Double-Blind, Randomized Study Comparing the Efficacy of Combination Therapy of Eprosartan Respectively Ramipril With Low-Dose Hydrochlorothiazide and Moxonidine on Blood Pressure Levels in Patients With Hypertension and Associated Diabetes Mellitus Type 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Type 2 Diabetes
Keywords: comparator trial
hypertension
diabetes
blood pressure
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 440
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* essential hypertension,
* diabetes type 2

Exclusion Criteria:

* severe cardiovascular disease,
* grade 3 hypertension,
* secondary hypertension,
* abnormal liver enzymes

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