Clinical trial NCT00160212: Study to Evaluate the Efficacy and Safety of SLV306 in Subjects With Hypertension
Official title: A Randomized, Placebo-Controlled, Double-Blind, Six-Arm, Dose Escalation, Multi-Center Study to Evaluate the Efficacy and Safety of SLV306: 150, 300, 600 mg Once Daily, 150-300 mg Twice Daily and Amlodipine 5-10 mg Once Daily in Subjects With Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypertension
Keywords: blood pressure
Lead sponsor: Solvay Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2005-09-12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is to compare the efficacy and safety of increasing doses of SLV306 with amlodipine.


Eligibility criteria: Inclusion Criteria:

* sitting office diastolic blood pressure between 90 and 109 mmHg
* office systolic blood pressure between 140 and 179 mmHg
* mean day-time diastolic 24-h ABPM blood pressure \>= 85 mmHg inclusive at baseline

Exclusion Criteria:

* known secondary hypertension
* decompensated congestive heart failure

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bracken Ridge
country: Australia
facility: Site 705
city: Caboolture
country: Australia
facility: Site 706
city: Inala
country: Australia
facility: Site 700
city: Kippa Ring
country: Australia
facility: Site 701
city: Melbourne
country: Australia
facility: Site 702
city: Nedlands
country: Australia
facility: Site 703
city: Haskovo
country: Bulgaria
facility: Site 952
city: Pleven
country: Bulgaria
facility: Site 955
city: Plovdiv
country: Bulgaria
facility: Site 951
city: Plovdiv
country: Bulgaria
facility: Site 956
city: Sofia
country: Bulgaria
facility: Site 950
city: Sofia
country: Bulgaria
facility: Site 953
city: Sofia
country: Bulgaria
facility: Site 954
city: Sofia
country: Bulgaria
facility: Site 957
city: Aalborg
country: Denmark
facility: Site 402
city: Ballerup
country: Denmark
facility: Site 401
city: Vejle
country: Denmark
facility: Site 403
city: Tallinn
country: Estonia
facility: Site 850
city: Aschaffenburg
country: Germany
facility: Site 119
city: Bad Nauheim
country: Germany
facility: Site 101
city: Bad Woerishofen
country: Germany
facility: Site 104
city: Beckum
country: Germany
facility: Site 106
city: Deidesheim
country: Germany
facility: Site 110
city: Karlsruhe
country: Germany
facility: Site 107
city: Kassel
country: Germany
facility: Site 118
city: Krombach
country: Germany
facility: Site 109
city: Ladenburg
country: Germany
facility: Site 113
city: Leipzig
country: Germany
facility: Site 102
city: Lollar
country: Germany
facility: Site 112
city: Magdeburg
country: Germany
facility: Site 114
city: Marburg
country: Germany
facility: Site 111
city: Muenster
country: Germany
facility: Site 105
city: Niederstetten
country: Germany
facility: Site 115
city: Rodgau Dudenhofen
country: Germany
facility: Site 120
city: Vellmar
country: Germany
facility: Site 116
city: Wiesbaden
country: Germany
facility: Site 103
city: Wolmirstedt
country: Germany
facility: Site 117
city: Budapest
country: Hungary
facility: Site 800
city: Budapest
country: Hungary
facility: Site 805
city: Gyongyos
country: Hungary
facility: Site 803
city: Kecskemet
country: Hungary
facility: Site 801
city: Pecs
country: Hungary
facility: Site 804
city: Szekesfehervar
country: Hungary
facility: Site 802
city: Ashkelon
country: Israel
facility: Site 300
city: Ashkelon
country: Israel
facility: Site 306
city: Beer Sheva
country: Israel
facility: Site 304
city: Haifa
country: Israel
facility: Site 311
city: Jerusalem
country: Israel
facility: Site 305
city: Kfar Saba
country: Israel
facility: Site 310
city: Kiryat Ata
country: Israel
facility: Site 303
city: Petach-Tikva
country: Israel
facility: Site 308
city: Tel-Aviv
country: Israel
facility: Site 302
city: Tel-Hashomer
country: Israel
facility: Site 301
city: Tiberias
country: Israel
facility: Site 309
city: Daugavpils
country: Latvia
facility: Site 932
city: Kuldiga
country: Latvia
facility: Site 930
city: Riga
country: Latvia
facility: Site 931
city: Riga
country: Latvia
facility: Site 933
city: Riga
country: Latvia
facility: Site 934
city: Riga
country: Latvia
facility: Site 935
city: Kaunas
country: Lithuania
facility: Site 920
city: Klaipeda
country: Lithuania
facility: Site 923
city: Vilnius
country: Lithuania
facility: Site 921
city: Bratislava
country: Slovakia
facility: Site 600
city: Bratislava
country: Slovakia
facility: Site 601
city: Kosice
country: Slovakia
facility: Site 607
city: Kosice
country: Slovakia
facility: Site 608
city: Levice
country: Slovakia
facility: Site 602
city: Lucenec
country: Slovakia
facility: Site 605
city: Nove Zamky
country: Slovakia
facility: Site 603
city: Vrable
country: Slovakia
facility: Site 606
city: Addlestone
country: United Kingdom
facility: Site 262
city: Airdrie
country: United Kingdom
facility: Site 229
city: Alexandria
country: United Kingdom
facility: Site 234
city: Bangor
country: United Kingdom
facility: Site 245
city: Barrhead
country: United Kingdom
facility: Site 241
city: Bath
country: United Kingdom
facility: Site 224
city: Bath
country: United Kingdom
facility: Site 240
city: Bellshill
country: United Kingdom
facility: Site 230
city: Bexhill on sea
country: United Kingdom
facility: Site 261
city: Bexhill- on-Sea
country: United Kingdom
facility: Site 243
city: Blackpool
country: United Kingdom
facility: Site 255
city: Blantyre
country: United Kingdom
facility: Site 222
city: Calderbank
country: United Kingdom
facility: Site 232
city: Chesterfield
country: United Kingdom
facility: Site 236
city: Chippenham
country: United Kingdom
facility: Site 219
city: Chippenham
country: United Kingdom
facility: Site 256
city: Co Tyrone
country: United Kingdom
facility: Site 237
city: Coatbridge
country: United Kingdom
facility: Site 216
city: Cornwall
country: United Kingdom
facility: Site 238
city: Coventry
country: United Kingdom
facility: Site 207
city: Cumbernauld
country: United Kingdom
facility: Site 247
city: Dumbarton
country: United Kingdom
facility: Site 208
city: East Horsley
country: United Kingdom
facility: Site 235
city: Ely
country: United Kingdom
facility: Site 220
city: Frome
country: United Kingdom
facility: Site 257
city: Glasgow
country: United Kingdom
facility: Site 210
city: Glasgow
country: United Kingdom
facility: Site 221
city: Glasgow
country: United Kingdom
facility: Site 227
city: Glasgow
country: United Kingdom
facility: Site 233
city: Glasgow
country: United Kingdom
facility: Site 251
city: Greenisland
country: United Kingdom
facility: Site 201
city: Helensburgh
country: United Kingdom
facility: Site 252
city: Hook
country: United Kingdom
facility: Site 249
city: Leamington SPA
country: United Kingdom
facility: Site 200
city: Maidenhead
country: United Kingdom
facility: Site 226
city: Maidenhead
country: United Kingdom
facility: Site 246
city: Manchester
country: United Kingdom
facility: Site 213
city: Melksham
country: United Kingdom
facility: Site 244
city: Middlesex
country: United Kingdom
facility: Site 259
city: Motherwell
country: United Kingdom
facility: Site 202
city: Motherwell
country: United Kingdom
facility: Site 206
city: Motherwell
country: United Kingdom
facility: Site 217
city: Motherwell
country: United Kingdom
facility: Site 239
city: Paisley
country: United Kingdom
facility: Site 231
city: Paisley
country: United Kingdom
facility: Site 250
city: Penzance
country: United Kingdom
facility: Site 242
city: Plymouth
country: United Kingdom
facility: Site 218
city: Plymouth
country: United Kingdom
facility: Site 223
city: Reading
country: United Kingdom
facility: Site 254
city: Riddrie
country: United Kingdom
facility: Site 212
city: Sandy
country: United Kingdom
facility: Site 253
city: Sheffield
country: United Kingdom
facility: Site 258
city: Slough
country: United Kingdom
facility: Site 205
city: St Just
country: United Kingdom
facility: Site 215
city: Strathaven
country: United Kingdom
facility: Site 211
city: Swansea
country: United Kingdom
facility: Site 225
city: Thornhill
country: United Kingdom
facility: Site 209
city: Wokingham
country: United Kingdom
facility: Site 228
city: Woking
country: United Kingdom
facility: Site 248
Study officials:
affiliation: Solvay Pharmaceuticals
name: Global Clinical Director Solvay
role: STUDY_DIRECTOR
References: