Trial Review

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00160212




Registration number
NCT00160212
Ethics application status
Date submitted
9/09/2005
Date registered
12/09/2005
Date last updated
30/01/2009

Titles & IDs
Public title
Study to Evaluate the Efficacy and Safety of SLV306 in Subjects With Hypertension
Scientific 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
Secondary ID [1] 0 0
2004-000305-21
Secondary ID [2] 0 0
S306.2.008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hypertension 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Hypertension

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Comparator / control treatment
Control group

Outcomes

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* known secondary hypertension
* decompensated congestive heart failure

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/12/2004
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site 705 - Bracken Ridge
Recruitment hospital [2] 0 0
Site 706 - Caboolture
Recruitment hospital [3] 0 0
Site 700 - Inala
Recruitment hospital [4] 0 0
Site 701 - Kippa Ring
Recruitment hospital [5] 0 0
Site 702 - Melbourne
Recruitment hospital [6] 0 0
Site 703 - Nedlands
Recruitment postcode(s) [1] 0 0
- Bracken Ridge
Recruitment postcode(s) [2] 0 0
- Caboolture
Recruitment postcode(s) [3] 0 0
- Inala
Recruitment postcode(s) [4] 0 0
- Kippa Ring
Recruitment postcode(s) [5] 0 0
- Melbourne
Recruitment postcode(s) [6] 0 0
- Nedlands
Recruitment outside Australia
Country [1] 0 0
Bulgaria
State/province [1] 0 0
Haskovo
Country [2] 0 0
Bulgaria
State/province [2] 0 0
Pleven
Country [3] 0 0
Bulgaria
State/province [3] 0 0
Plovdiv
Country [4] 0 0
Bulgaria
State/province [4] 0 0
Sofia
Country [5] 0 0
Denmark
State/province [5] 0 0
Aalborg
Country [6] 0 0
Denmark
State/province [6] 0 0
Ballerup
Country [7] 0 0
Denmark
State/province [7] 0 0
Vejle
Country [8] 0 0
Estonia
State/province [8] 0 0
Tallinn
Country [9] 0 0
Germany
State/province [9] 0 0
Aschaffenburg
Country [10] 0 0
Germany
State/province [10] 0 0
Bad Nauheim
Country [11] 0 0
Germany
State/province [11] 0 0
Bad Woerishofen
Country [12] 0 0
Germany
State/province [12] 0 0
Beckum
Country [13] 0 0
Germany
State/province [13] 0 0
Deidesheim
Country [14] 0 0
Germany
State/province [14] 0 0
Karlsruhe
Country [15] 0 0
Germany
State/province [15] 0 0
Kassel
Country [16] 0 0
Germany
State/province [16] 0 0
Krombach
Country [17] 0 0
Germany
State/province [17] 0 0
Ladenburg
Country [18] 0 0
Germany
State/province [18] 0 0
Leipzig
Country [19] 0 0
Germany
State/province [19] 0 0
Lollar
Country [20] 0 0
Germany
State/province [20] 0 0
Magdeburg
Country [21] 0 0
Germany
State/province [21] 0 0
Marburg
Country [22] 0 0
Germany
State/province [22] 0 0
Muenster
Country [23] 0 0
Germany
State/province [23] 0 0
Niederstetten
Country [24] 0 0
Germany
State/province [24] 0 0
Rodgau Dudenhofen
Country [25] 0 0
Germany
State/province [25] 0 0
Vellmar
Country [26] 0 0
Germany
State/province [26] 0 0
Wiesbaden
Country [27] 0 0
Germany
State/province [27] 0 0
Wolmirstedt
Country [28] 0 0
Hungary
State/province [28] 0 0
Budapest
Country [29] 0 0
Hungary
State/province [29] 0 0
Gyongyos
Country [30] 0 0
Hungary
State/province [30] 0 0
Kecskemet
Country [31] 0 0
Hungary
State/province [31] 0 0
Pecs
Country [32] 0 0
Hungary
State/province [32] 0 0
Szekesfehervar
Country [33] 0 0
Israel
State/province [33] 0 0
Ashkelon
Country [34] 0 0
Israel
State/province [34] 0 0
Beer Sheva
Country [35] 0 0
Israel
State/province [35] 0 0
Haifa
Country [36] 0 0
Israel
State/province [36] 0 0
Jerusalem
Country [37] 0 0
Israel
State/province [37] 0 0
Kfar Saba
Country [38] 0 0
Israel
State/province [38] 0 0
Kiryat Ata
Country [39] 0 0
Israel
State/province [39] 0 0
Petach-Tikva
Country [40] 0 0
Israel
State/province [40] 0 0
Tel-Aviv
Country [41] 0 0
Israel
State/province [41] 0 0
Tel-Hashomer
Country [42] 0 0
Israel
State/province [42] 0 0
Tiberias
Country [43] 0 0
Latvia
State/province [43] 0 0
Daugavpils
Country [44] 0 0
Latvia
State/province [44] 0 0
Kuldiga
Country [45] 0 0
Latvia
State/province [45] 0 0
Riga
Country [46] 0 0
Lithuania
State/province [46] 0 0
Kaunas
Country [47] 0 0
Lithuania
State/province [47] 0 0
Klaipeda
Country [48] 0 0
Lithuania
State/province [48] 0 0
Vilnius
Country [49] 0 0
Slovakia
State/province [49] 0 0
Bratislava
Country [50] 0 0
Slovakia
State/province [50] 0 0
Kosice
Country [51] 0 0
Slovakia
State/province [51] 0 0
Levice
Country [52] 0 0
Slovakia
State/province [52] 0 0
Lucenec
Country [53] 0 0
Slovakia
State/province [53] 0 0
Nove Zamky
Country [54] 0 0
Slovakia
State/province [54] 0 0
Vrable
Country [55] 0 0
United Kingdom
State/province [55] 0 0
Addlestone
Country [56] 0 0
United Kingdom
State/province [56] 0 0
Airdrie
Country [57] 0 0
United Kingdom
State/province [57] 0 0
Alexandria
Country [58] 0 0
United Kingdom
State/province [58] 0 0
Bangor
Country [59] 0 0
United Kingdom
State/province [59] 0 0
Barrhead
Country [60] 0 0
United Kingdom
State/province [60] 0 0
Bath
Country [61] 0 0
United Kingdom
State/province [61] 0 0
Bellshill
Country [62] 0 0
United Kingdom
State/province [62] 0 0
Bexhill on sea
Country [63] 0 0
United Kingdom
State/province [63] 0 0
Bexhill- on-Sea
Country [64] 0 0
United Kingdom
State/province [64] 0 0
Blackpool
Country [65] 0 0
United Kingdom
State/province [65] 0 0
Blantyre
Country [66] 0 0
United Kingdom
State/province [66] 0 0
Calderbank
Country [67] 0 0
United Kingdom
State/province [67] 0 0
Chesterfield
Country [68] 0 0
United Kingdom
State/province [68] 0 0
Chippenham
Country [69] 0 0
United Kingdom
State/province [69] 0 0
Co Tyrone
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Coatbridge
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Cornwall
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Coventry
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Cumbernauld
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Dumbarton
Country [75] 0 0
United Kingdom
State/province [75] 0 0
East Horsley
Country [76] 0 0
United Kingdom
State/province [76] 0 0
Ely
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Frome
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Glasgow
Country [79] 0 0
United Kingdom
State/province [79] 0 0
Greenisland
Country [80] 0 0
United Kingdom
State/province [80] 0 0
Helensburgh
Country [81] 0 0
United Kingdom
State/province [81] 0 0
Hook
Country [82] 0 0
United Kingdom
State/province [82] 0 0
Leamington SPA
Country [83] 0 0
United Kingdom
State/province [83] 0 0
Maidenhead
Country [84] 0 0
United Kingdom
State/province [84] 0 0
Manchester
Country [85] 0 0
United Kingdom
State/province [85] 0 0
Melksham
Country [86] 0 0
United Kingdom
State/province [86] 0 0
Middlesex
Country [87] 0 0
United Kingdom
State/province [87] 0 0
Motherwell
Country [88] 0 0
United Kingdom
State/province [88] 0 0
Paisley
Country [89] 0 0
United Kingdom
State/province [89] 0 0
Penzance
Country [90] 0 0
United Kingdom
State/province [90] 0 0
Plymouth
Country [91] 0 0
United Kingdom
State/province [91] 0 0
Reading
Country [92] 0 0
United Kingdom
State/province [92] 0 0
Riddrie
Country [93] 0 0
United Kingdom
State/province [93] 0 0
Sandy
Country [94] 0 0
United Kingdom
State/province [94] 0 0
Sheffield
Country [95] 0 0
United Kingdom
State/province [95] 0 0
Slough
Country [96] 0 0
United Kingdom
State/province [96] 0 0
St Just
Country [97] 0 0
United Kingdom
State/province [97] 0 0
Strathaven
Country [98] 0 0
United Kingdom
State/province [98] 0 0
Swansea
Country [99] 0 0
United Kingdom
State/province [99] 0 0
Thornhill
Country [100] 0 0
United Kingdom
State/province [100] 0 0
Wokingham
Country [101] 0 0
United Kingdom
State/province [101] 0 0
Woking

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Solvay Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Global Clinical Director Solvay
Address 0 0
Solvay Pharmaceuticals
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT00160212