HypertensionPhase 2NCT00160212
Study to Evaluate the Efficacy and Safety of SLV306 in Subjects With Hypertension
A Phase 2 study testing Daglutril in people with Hypertension, run by Solvay Pharmaceuticals at 130 sites in 11 countries.
Trial summary
This study is to compare the efficacy and safety of increasing doses of SLV306 with amlodipine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Daglutril
- How many people
- Not given
- Where
- 130 sitesin 11 countries
- Study dates
- Dec 2004to not given
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- known secondary hypertension
- decompensated congestive heart failure
Trial locations and contacts
130 sites in 11 countries.
130 sites in 11 countries
United Kingdom59 sites
Site 262
Addlestone
Site 229
Airdrie
Site 234
Alexandria
Site 245
Bangor
Site 241
Barrhead
Site 224
Bath
Site 240
Bath
Site 230
Bellshill
Site 243
Bexhill-on-Sea
Site 261
Bexhill-on-Sea
Site 255
Blackpool
Site 222
Blantyre
Site 232
Calderbank
Site 236
Chesterfield
Site 219
Chippenham
Site 256
Chippenham
Site 237
Co Tyrone
Site 216
Coatbridge
Site 238
Cornwall
Site 207
Coventry
Site 247
Cumbernauld
Site 208
Dumbarton
Site 235
East Horsley
Site 220
Ely
Site 257
Frome
Site 210
Glasgow
Site 221
Glasgow
Site 227
Glasgow
Site 233
Glasgow
Site 251
Glasgow
Site 201
Greenisland
Site 252
Helensburgh
Site 249
Hook
Site 226
Maidenhead
Site 246
Maidenhead
Site 213
Manchester
Site 244
Melksham
Site 259
Middlesex
Site 202
Motherwell
Site 206
Motherwell
Site 217
Motherwell
Site 239
Motherwell
Site 231
Paisley
Site 250
Paisley
Site 242
Penzance
Site 218
Plymouth
Site 223
Plymouth
Site 254
Reading
Site 212
Riddrie
Site 200
Royal Leamington Spa
Site 253
Sandy
Site 258
Sheffield
Site 205
Slough
Site 215
St Just
Site 211
Strathaven
Site 225
Swansea
Site 209
Thornhill
Site 248
Woking
Site 228
Wokingham
Germany19 sites
Site 119
Aschaffenburg
Site 101
Bad Nauheim
Site 104
Bad Wörishofen
Site 106
Beckum
Site 110
Deidesheim
Site 107
Karlsruhe
Site 118
Kassel
Site 109
Krombach
Site 113
Ladenburg
Site 102
Leipzig
Site 112
Lollar
Site 114
Magdeburg
Site 111
Marburg
Site 105
Münster
Site 115
Niederstetten
Site 120
Rodgau Dudenhofen
Site 116
Vellmar
Site 103
Wiesbaden
Site 117
Wolmirstedt
Israel11 sites
Site 300
Ashkelon
Site 306
Ashkelon
Site 304
Beersheba
Site 311
Haifa
Site 305
Jerusalem
Site 310
Kfar Saba
Site 303
Kiryat Ata
Site 308
Petah Tikva
Site 302
Tel Aviv
Site 301
Tel HaShomer
Site 309
Tiberias
Bulgaria8 sites
Site 952
Haskovo
Site 955
Pleven
Site 951
Plovdiv
Site 956
Plovdiv
Site 950
Sofia
Site 953
Sofia
Site 954
Sofia
Site 957
Sofia
Slovakia8 sites
Site 600
Bratislava
Site 601
Bratislava
Site 607
Košice
Site 608
Košice
Site 602
Levice
Site 605
Lučenec
Site 603
Nové Zámky
Site 606
Vráble
Australia6 sites
Site 705
Bracken Ridge
Site 706
Caboolture
Site 700
Inala
Site 701
Kippa-Ring
Site 702
Melbourne
Site 703
Nedlands
Hungary6 sites
Site 800
Budapest
Site 805
Budapest
Site 803
Gyöngyös
Site 801
Kecskemét
Site 804
Pécs
Site 802
Székesfehérvár
Latvia6 sites
Site 932
Daugavpils
Site 930
Kuldīga
Site 931
Riga
Site 933
Riga
Site 934
Riga
Site 935
Riga
About this study
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
This study is to compare the efficacy and safety of increasing doses of SLV306 with amlodipine.
- Conditions
- Hypertension
- Being tested
- Daglutril
- Keywords
- blood pressure
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaglutrilDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Sponsor and investigators
- Lead sponsor
- Solvay Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Global Clinical Director Solvay, Study director, Solvay Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00160212
- Sponsor's protocol ID
- S306.2.008
- Other IDs
- 2004-000305-21, 2004
- Status last verified
- Jan 2009
- First submitted
- 9 Sep 2005
- Last updated
- 30 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00160212
- Acronym / sponsor ID
- S306.2.008
- Conditions
- Hypertension
- Keywords
- blood pressure
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Solvay PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- First posted
- 12 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to compare the efficacy and safety of increasing doses of SLV306 with amlodipine.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- known secondary hypertension
- decompensated congestive heart failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Daglutril | Drug | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Director Solvay study director
Solvay Pharmaceuticals
130 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Daglutril in people with Hypertension, run by Solvay Pharmaceuticals at 130 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 130 sites in United Kingdom, Germany, Israel, Bulgaria, Slovakia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2009.