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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
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Bulgaria
State/province [2] 0 0
Pleven
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Bulgaria
State/province [3] 0 0
Plovdiv
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Bulgaria
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Sofia
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Denmark
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Aalborg
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Denmark
State/province [6] 0 0
Ballerup
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Denmark
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Vejle
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Estonia
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Tallinn
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Germany
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Aschaffenburg
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Germany
State/province [10] 0 0
Bad Nauheim
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Germany
State/province [11] 0 0
Bad Woerishofen
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Germany
State/province [12] 0 0
Beckum
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Germany
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Deidesheim
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Germany
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Karlsruhe
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Germany
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Kassel
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Germany
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Krombach
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Germany
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Ladenburg
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Germany
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Leipzig
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Germany
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Lollar
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Germany
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Magdeburg
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Germany
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Marburg
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Germany
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Muenster
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Germany
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Niederstetten
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Germany
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Rodgau Dudenhofen
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Germany
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Vellmar
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Germany
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Wiesbaden
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Germany
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Wolmirstedt
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Hungary
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Budapest
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Hungary
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Gyongyos
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Hungary
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Kecskemet
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Hungary
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Pecs
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Hungary
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Szekesfehervar
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Israel
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Ashkelon
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Kfar Saba
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Kiryat Ata
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Cumbernauld
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Dumbarton
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Ely
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Wokingham
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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