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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01572727




Registration number
NCT01572727
Ethics application status
Date submitted
4/04/2012
Date registered
6/04/2012
Date last updated
9/03/2017

Titles & IDs
Public title
A Study of the Experimental Drug BKM120 With Paclitaxel in Patients With HER2 Negative, Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Activation
Scientific title
A Randomized, Double-blind, Placebo Controlled, Phase II/III Study of BKM120 Plus Paclitaxel in Patients With HER2 Negative Inoperable Locally Advanced or Metastatic Breast Cancer, With or Without PI3K Pathway Activation.
Secondary ID [1] 0 0
2011-005932-24
Secondary ID [2] 0 0
CBKM120F2202
Universal Trial Number (UTN)
Trial acronym
BELLE-4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Paclitaxel
Treatment: Drugs - BKM120 matching placebo
Treatment: Drugs - BKM120

Experimental: BKM120 and paclitaxel - Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received study drug plus paclitaxel.

Active comparator: Placebo and paclitaxel - Adult females with histologically confirmed, inoperable, locally advanced or metastatic HER2- BC who received placebo plus paclitaxel.


Treatment: Drugs: Paclitaxel
intravenous paclitaxel 80 mg/m2 per week given until progression

Treatment: Drugs: BKM120 matching placebo
Buparlisib maching plaxcebo were supplied as 100 mg and 50 mg hard gelatin capsules.

Buparlisib placebo was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.

Treatment: Drugs: BKM120
Buparlisib (BKM120) were supplied as 100 mg and 50 mg hard gelatin capsules. Buparlisib was dosed on a flat scale of mg/day and was not adjusted to body weight or body surface area.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)Assessed by Local Investigator's Assessment (Phase ll)
Timepoint [1] 0 0
Every 8 weeks from randomization until disease progression up to 10 months after futility was analyzed
Secondary outcome [1] 0 0
Overall Survival by Kaplan-Meier Estimate (Phase ll)
Timepoint [1] 0 0
every 3 months until death, lost to follow-up, or withdrawal of consent to survival follow-up, up to 10 months after futility was analyzed
Secondary outcome [2] 0 0
Overall Response Rate (Phase ll)
Timepoint [2] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [3] 0 0
Duration of Response (Phase Lll)
Timepoint [3] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [4] 0 0
Time to Response (Phase Lll)
Timepoint [4] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [5] 0 0
Clinical Benefit Rate (CBR) (Phase ll)
Timepoint [5] 0 0
every 8 weeks after randomization Up to 3 months after end of Treatment
Secondary outcome [6] 0 0
Plasma Concentration-time Profiles of BKM120 - Pharmacokinetics (PK) (Phase Lll)
Timepoint [6] 0 0
Cycle 1 day 1, 15, 16, 22 and Cycle 2 day 1.
Secondary outcome [7] 0 0
Time to Definitive Deterioration of ECOG Performance Status (Phase Lll)
Timepoint [7] 0 0
every 4 weeks

Eligibility
Key inclusion criteria
* Breast cancer that is locally advanced or metastatic
* HER2 negative disease, and a known hormone receptor status - ER/PgR (common breast cancer classification tests)
* A tumor sample must be shipped to a central lab for identification of biomarkers (PI3K activation status) before randomization
* Adequate bone marrow and organ function
* Measurable or non-measurable disease
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior chemotherapy for locally advanced or metastatic disease
* Previous treatment with PI3K or AKT inhibitors
* Patient has symptomatic CNS metastases
* Concurrent malignancy or malignancy within 3 years of study enrollment
* Hematopoietic colony-stimulating growth factors or radiation within 2-4 weeks prior to starting study drug
* Increasing or chronic treatment (> 5 days) with corticosteroids or another immunosuppressive agent
* Active heart (cardiac) disease as defined in the protocol
* Known hypersensitivity or contraindications to use paclitaxel
* Pregnant or nursing (lactating) woman
* Certain scores on an anxiety and depression mood questionaire given at screening
* Other protocol defined criteria may apply

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?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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
1/08/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/06/2015
Sample size
Target
Accrual to date
Final
416
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Sydney
Recruitment hospital [2] 0 0
Novartis Investigative Site - Geelong
Recruitment hospital [3] 0 0
Novartis Investigative Site - Parkville
Recruitment hospital [4] 0 0
Novartis Investigative Site - Nedlands
Recruitment postcode(s) [1] 0 0
2060 - Sydney
Recruitment postcode(s) [2] 0 0
3220 - Geelong
Recruitment postcode(s) [3] 0 0
3050 - Parkville
Recruitment postcode(s) [4] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Arkansas
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United States of America
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California
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United States of America
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Colorado
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United States of America
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Florida
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United States of America
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Georgia
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United States of America
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Kansas
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United States of America
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Kentucky
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United States of America
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Missouri
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United States of America
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Nebraska
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New Mexico
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New York
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Ohio
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Oklahoma
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United States of America
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Oregon
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United States of America
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Texas
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United States of America
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Virginia
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Austria
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Salzburg
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Austria
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Vienna
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Belgium
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Charleroi
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Belgium
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Liege
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Belgium
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Liège
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Belgium
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Ottignies
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Belgium
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Sint-Niklaas
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Belgium
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Wilrijk
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Brazil
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CE
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Brazil
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SP
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Canada
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Quebec
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Czech Republic
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Brno
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Czech Republic
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Olomouc
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Czech Republic
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Praha 2
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France
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Angers Cedex 02
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France
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Bordeaux
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France
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Creteil
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France
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La Roche sur Yon cedex 9
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France
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Le Mans Cedex
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France
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Marseille
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France
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Nice Cedex 2
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France
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Saint Herblain cedex
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France
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Toulouse Cedex 9
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France
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Villejuif Cedex
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Germany
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Bonn
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Germany
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Dresden
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Germany
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Erlangen
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Germany
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Frankfurt
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Germany
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Fulda
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Germany
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Mainz
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Germany
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Muenchen
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Germany
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Ravensburg
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Germany
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Ulm
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Hong Kong
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Hong Kong SAR
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Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Szolnok
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Israel
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Ramat Gan
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Israel
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Tel Aviv
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Italy
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FE
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Italy
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GE
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Italy
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MB
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Italy
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ME
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Italy
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MI
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Japan
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Aichi
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Japan
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Hokkaido
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Japan
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Kanagawa
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Japan
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Kumamoto
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Japan
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Osaka
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Japan
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Tokyo
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Korea, Republic of
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Korea
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Netherlands
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Breda
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Netherlands
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Rotterdam
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Russian Federation
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Russia
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Russian Federation
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St. Petersburg
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Singapore
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Singapore
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South Africa
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Johannesburg
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Spain
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Andalucia
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Spain
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Catalunya
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Spain
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Comunidad Valenciana
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Spain
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Galicia
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Santa Cruz de Tenerife
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Spain
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Madrid
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Spain
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Zaragoza
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Taiwan
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Taoyuan/ Taiwan ROC
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Taiwan
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New Taipei City
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Taiwan
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Taipei
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United Kingdom
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Kent
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United Kingdom
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Glasgow - Scotland
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United Kingdom
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London
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United Kingdom
State/province [88] 0 0
Wirral

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis 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
Novartis Pharmaceuticals
Address 0 0
Novartis 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 are available at https://clinicaltrials.gov/study/NCT01572727