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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
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
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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
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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
State/province [15] 0 0
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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Haifa
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Jerusalem
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Kfar Saba
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Tiberias
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Ely
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Maidenhead
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Melksham
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Middlesex
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Motherwell
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Sandy
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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
This study is to compare the efficacy and safety of increasing doses of SLV306 with amlodipine.
Trial website
https://clinicaltrials.gov/study/NCT00160212
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00160212