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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00160212
Other study ID # S306.2.008
Secondary ID 2004-000305-21
Status Completed
Phase Phase 2
First received September 9, 2005
Last updated January 29, 2009
Start date December 2004

Study information

Verified date January 2009
Source Solvay Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationLatvia: State Agency of MedicinesGermany: Federal Institute for Drugs and Medical DevicesSlovakia: State Institute for Drug ControlHungary: National Institute of PharmacyAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBulgaria: Bulgarian Drug AgencyEstonia: The State Agency of MedicineLithuania: State Medicine Control Agency - Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyIsrael: Israeli Health Ministry Pharmaceutical AdministrationDenmark: Danish Medicines Agency
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Daglutril


Locations

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

Sponsors (1)

Lead Sponsor Collaborator
Solvay Pharmaceuticals

Countries where clinical trial is conducted

Australia,  Bulgaria,  Denmark,  Estonia,  Germany,  Hungary,  Israel,  Latvia,  Lithuania,  Slovakia,  United Kingdom, 

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