Study to Evaluate the Efficacy and Safety of SLV306 in Subjects With Hypertension

January 29, 2009 updated by: Solvay Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Hypertension

Intervention / Treatment

Drug: Daglutril

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Solvay Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 12, 2005

Study Record Updates

Last Update Posted (Estimate)

January 30, 2009

Last Update Submitted That Met QC Criteria

January 29, 2009

Last Verified

January 1, 2009

More Information

Terms related to this study

Keywords

blood pressure

Additional Relevant MeSH Terms

Other Study ID Numbers

S306.2.008
2004-000305-21

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.