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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00073528




Registration number
NCT00073528
Ethics application status
Date submitted
24/11/2003
Date registered
26/11/2003

Titles & IDs
Public title
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
CLAP016A2308
Secondary ID [2] 0 0
EGF30008
Universal Trial Number (UTN)
Trial acronym
Linked study record

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

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lapatinib
Treatment: Drugs - Letrozole
Treatment: Drugs - Placebo

Placebo comparator: Placebo + Letrozole 2.5 mg - Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)

Experimental: Lapatinib 1500 mg + Letrozole 2.5 mg - Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)


Treatment: Drugs: Lapatinib
1500 mg orally once a day

Treatment: Drugs: Letrozole
2.5 mg orally once a day

Treatment: Drugs: Placebo
Placebo (which matched with lapatinib tablet)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator
Timepoint [1] 0 0
From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months
Primary outcome [2] 0 0
Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [1] 0 0
Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator
Timepoint [1] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [2] 0 0
PFS in Participants in the ITT Population as Assessed by the Investigator
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [3] 0 0
Overall Survival in the HER2-Positive Population
Timepoint [3] 0 0
From date of randomization until date of death due to any cause, assessed up to 46 months
Secondary outcome [4] 0 0
Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Timepoint [4] 0 0
Up to 46 months
Secondary outcome [5] 0 0
Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Timepoint [5] 0 0
Up to 46 months
Secondary outcome [6] 0 0
Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator
Timepoint [6] 0 0
Up to 46 months
Secondary outcome [7] 0 0
Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.
Timepoint [7] 0 0
Up to 46 months
Secondary outcome [8] 0 0
Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.
Timepoint [8] 0 0
Up to 46 months
Secondary outcome [9] 0 0
Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator
Timepoint [9] 0 0
Up to 46 months
Secondary outcome [10] 0 0
Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator
Timepoint [10] 0 0
Up to 46 months
Secondary outcome [11] 0 0
Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population
Timepoint [11] 0 0
Up to 46 months
Secondary outcome [12] 0 0
Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator
Timepoint [12] 0 0
Up to 46 months
Secondary outcome [13] 0 0
Overall Survival in the ITT Population
Timepoint [13] 0 0
From date of randomization until date of death due to any cause, assessed up to 46 months
Secondary outcome [14] 0 0
Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator
Timepoint [14] 0 0
Up to 46 months
Secondary outcome [15] 0 0
Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator
Timepoint [15] 0 0
Up to 46 months
Secondary outcome [16] 0 0
Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator
Timepoint [16] 0 0
Up to 46 months
Secondary outcome [17] 0 0
Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator
Timepoint [17] 0 0
Up to 46 months
Secondary outcome [18] 0 0
Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator
Timepoint [18] 0 0
Up to 46 months
Secondary outcome [19] 0 0
Number of Participants With Evidence of Brain Metastases From the ITT Population
Timepoint [19] 0 0
Up to 46 months
Secondary outcome [20] 0 0
TTP for Participants From the ITT Population as Assessed by the Investigator
Timepoint [20] 0 0
Up to 46 months
Secondary outcome [21] 0 0
Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits
Timepoint [21] 0 0
Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit
Secondary outcome [22] 0 0
Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data
Timepoint [22] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [23] 0 0
Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data
Timepoint [23] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [24] 0 0
Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data
Timepoint [24] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [25] 0 0
Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores
Timepoint [25] 0 0
Up to 46 months
Secondary outcome [26] 0 0
Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status
Timepoint [26] 0 0
Up to 46 months
Secondary outcome [27] 0 0
Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity
Timepoint [27] 0 0
Up to 46 months
Secondary outcome [28] 0 0
Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower
Timepoint [28] 0 0
Up to 46 months
Secondary outcome [29] 0 0
Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive
Timepoint [29] 0 0
Up to 46 months
Secondary outcome [30] 0 0
Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive
Timepoint [30] 0 0
Up to 46 months
Secondary outcome [31] 0 0
Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline
Timepoint [31] 0 0
Baseline

Eligibility
Key inclusion criteria
Key inclusion criteria

1. Signed informed consent;
2. Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;

* Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
* If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.
3. Tumors that were ER+ and/or PgR+;
4. Post-menopausal female subjects = 18 years of age.
5. ECOG Performance Status of 0 or 1;
6. Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
7. Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy.
8. Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.

Key exclusion criteria:

1. Pre-menopausal, pregnant, or lactating;
2. Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;
3. Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;
4. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);
5. Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)
6. Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

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 3
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
9/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/03/2018
Sample size
Target
Accrual to date
Final
1286
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Garran
Recruitment hospital [2] 0 0
Novartis Investigative Site - Douglas
Recruitment hospital [3] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [4] 0 0
Novartis Investigative Site - Redcliffe
Recruitment hospital [5] 0 0
Novartis Investigative Site - Adelaide
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
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
Country [3] 0 0
United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
Country [5] 0 0
United States of America
State/province [5] 0 0
Connecticut
Country [6] 0 0
United States of America
State/province [6] 0 0
Florida
Country [7] 0 0
United States of America
State/province [7] 0 0
Georgia
Country [8] 0 0
United States of America
State/province [8] 0 0
Illinois
Country [9] 0 0
United States of America
State/province [9] 0 0
Indiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Iowa
Country [11] 0 0
United States of America
State/province [11] 0 0
Kentucky
Country [12] 0 0
United States of America
State/province [12] 0 0
Louisiana
Country [13] 0 0
United States of America
State/province [13] 0 0
Massachusetts
Country [14] 0 0
United States of America
State/province [14] 0 0
Minnesota
Country [15] 0 0
United States of America
State/province [15] 0 0
Missouri
Country [16] 0 0
United States of America
State/province [16] 0 0
Nebraska
Country [17] 0 0
United States of America
State/province [17] 0 0
Nevada
Country [18] 0 0
United States of America
State/province [18] 0 0
New Jersey
Country [19] 0 0
United States of America
State/province [19] 0 0
New Mexico
Country [20] 0 0
United States of America
State/province [20] 0 0
New York
Country [21] 0 0
United States of America
State/province [21] 0 0
North Carolina
Country [22] 0 0
United States of America
State/province [22] 0 0
North Dakota
Country [23] 0 0
United States of America
State/province [23] 0 0
Ohio
Country [24] 0 0
United States of America
State/province [24] 0 0
Pennsylvania
Country [25] 0 0
United States of America
State/province [25] 0 0
South Carolina
Country [26] 0 0
United States of America
State/province [26] 0 0
Tennessee
Country [27] 0 0
United States of America
State/province [27] 0 0
Texas
Country [28] 0 0
United States of America
State/province [28] 0 0
Utah
Country [29] 0 0
United States of America
State/province [29] 0 0
Vermont
Country [30] 0 0
United States of America
State/province [30] 0 0
Virginia
Country [31] 0 0
United States of America
State/province [31] 0 0
Washington
Country [32] 0 0
United States of America
State/province [32] 0 0
West Virginia
Country [33] 0 0
Argentina
State/province [33] 0 0
Buenos Aires
Country [34] 0 0
Argentina
State/province [34] 0 0
Ciudad Autonoma de Buenos Aires
Country [35] 0 0
Brazil
State/province [35] 0 0
Bahía
Country [36] 0 0
Brazil
State/province [36] 0 0
Rio de Janeiro
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Plovdiv
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Sofia
Country [39] 0 0
Canada
State/province [39] 0 0
Manitoba
Country [40] 0 0
Canada
State/province [40] 0 0
Ontario
Country [41] 0 0
Canada
State/province [41] 0 0
Quebec
Country [42] 0 0
Chile
State/province [42] 0 0
Región Metro De Santiago
Country [43] 0 0
Colombia
State/province [43] 0 0
Bogota
Country [44] 0 0
Croatia
State/province [44] 0 0
Osijek
Country [45] 0 0
Croatia
State/province [45] 0 0
Pula
Country [46] 0 0
Croatia
State/province [46] 0 0
Split
Country [47] 0 0
Czechia
State/province [47] 0 0
Brno
Country [48] 0 0
Czechia
State/province [48] 0 0
Ceske Budejovice
Country [49] 0 0
Czechia
State/province [49] 0 0
Praha 8
Country [50] 0 0
Denmark
State/province [50] 0 0
Aalborg
Country [51] 0 0
Denmark
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Hillerod
Country [52] 0 0
Denmark
State/province [52] 0 0
Koebenhavn Oe
Country [53] 0 0
Denmark
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Naestved
Country [54] 0 0
Denmark
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Odense C
Country [55] 0 0
Denmark
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Roskilde
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Denmark
State/province [56] 0 0
Vejle
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France
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Angers Cedex 01
Country [58] 0 0
France
State/province [58] 0 0
Besancon
Country [59] 0 0
France
State/province [59] 0 0
Grenoble Cedex 9
Country [60] 0 0
France
State/province [60] 0 0
Lille Cedex
Country [61] 0 0
France
State/province [61] 0 0
Montpellier
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France
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Paris Cedex 5
Country [63] 0 0
France
State/province [63] 0 0
Pierre Benite Cedex
Country [64] 0 0
France
State/province [64] 0 0
Toulouse Cedex9
Country [65] 0 0
France
State/province [65] 0 0
Villejuif Cedex
Country [66] 0 0
Germany
State/province [66] 0 0
Baden-Wuerttemberg
Country [67] 0 0
Germany
State/province [67] 0 0
Bayern
Country [68] 0 0
Germany
State/province [68] 0 0
Hessen
Country [69] 0 0
Germany
State/province [69] 0 0
Niedersachsen
Country [70] 0 0
Germany
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Nordrhein-Westfalen
Country [71] 0 0
Germany
State/province [71] 0 0
Rheinland-Pfalz
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Germany
State/province [72] 0 0
Sachsen
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Germany
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Schleswig-Holstein
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Germany
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Thueringen
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Germany
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Berlin
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Germany
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Hamburg
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Hungary
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Budapest
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Hungary
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Kecskemet
Country [79] 0 0
Hungary
State/province [79] 0 0
Kistarcsa
Country [80] 0 0
Hungary
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Szeged
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Hungary
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Tatabanya
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Ireland
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Cork
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Ireland
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Dooradoyle
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Ireland
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Dublin
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Ireland
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Galway
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Ireland
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Tallaght, Dublin
Country [87] 0 0
Ireland
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Wilton, Cork
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Italy
State/province [88] 0 0
Emilia-Romagna
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Italy
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Lazio
Country [90] 0 0
Italy
State/province [90] 0 0
Liguria
Country [91] 0 0
Italy
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Lombardia
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Gyeonggi-do
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Seodaemun-gu, Seoul
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seoul
Country [95] 0 0
Mexico
State/province [95] 0 0
Guerrero
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Mexico
State/province [96] 0 0
Colima
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Mexico
State/province [97] 0 0
Durango
Country [98] 0 0
Mexico
State/province [98] 0 0
Mexico, D.F.
Country [99] 0 0
Netherlands
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Amersfoort
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Netherlands
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Delft
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Netherlands
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Den Haag
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Netherlands
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Doetinchem
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Netherlands
State/province [103] 0 0
Eindhoven
Country [104] 0 0
Netherlands
State/province [104] 0 0
Heerlen
Country [105] 0 0
Netherlands
State/province [105] 0 0
Leidschendam
Country [106] 0 0
Netherlands
State/province [106] 0 0
Maastricht
Country [107] 0 0
Netherlands
State/province [107] 0 0
Nieuwegein
Country [108] 0 0
Netherlands
State/province [108] 0 0
Sittard-geleen
Country [109] 0 0
Netherlands
State/province [109] 0 0
Utrecht
Country [110] 0 0
New Zealand
State/province [110] 0 0
Christchurch
Country [111] 0 0
Pakistan
State/province [111] 0 0
Lahore
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Pakistan
State/province [112] 0 0
Rawalpindi
Country [113] 0 0
Peru
State/province [113] 0 0
Callao
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Peru
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Lima
Country [115] 0 0
Poland
State/province [115] 0 0
Bydogoszcz
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Poland
State/province [116] 0 0
Krakow
Country [117] 0 0
Poland
State/province [117] 0 0
Poznan
Country [118] 0 0
Poland
State/province [118] 0 0
Warszawa
Country [119] 0 0
Poland
State/province [119] 0 0
Wroclaw
Country [120] 0 0
Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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South Africa
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Capital Park
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South Africa
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Panorama
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South Africa
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Parktown
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South Africa
State/province [125] 0 0
Port Elizabeth
Country [126] 0 0
Spain
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Alcala De Henares (Madrid)
Country [127] 0 0
Spain
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Badalona
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Spain
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Barcelona
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Spain
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Elche
Country [130] 0 0
Spain
State/province [130] 0 0
Girona
Country [131] 0 0
Spain
State/province [131] 0 0
Leganes, Madrid
Country [132] 0 0
Spain
State/province [132] 0 0
Madrid
Country [133] 0 0
Spain
State/province [133] 0 0
Malaga
Country [134] 0 0
Spain
State/province [134] 0 0
Mostoles
Country [135] 0 0
Spain
State/province [135] 0 0
Oviedo
Country [136] 0 0
Spain
State/province [136] 0 0
Palma de Mallorca
Country [137] 0 0
Spain
State/province [137] 0 0
San Sebastian
Country [138] 0 0
Spain
State/province [138] 0 0
Valencia
Country [139] 0 0
Spain
State/province [139] 0 0
Vigo ( Pontevedra)
Country [140] 0 0
Spain
State/province [140] 0 0
Zaragoza
Country [141] 0 0
Tunisia
State/province [141] 0 0
Sfax
Country [142] 0 0
Tunisia
State/province [142] 0 0
Sousse
Country [143] 0 0
Tunisia
State/province [143] 0 0
Tunis
Country [144] 0 0
Turkey
State/province [144] 0 0
Ankara
Country [145] 0 0
Turkey
State/province [145] 0 0
Istanbul
Country [146] 0 0
United Kingdom
State/province [146] 0 0
Essex
Country [147] 0 0
United Kingdom
State/province [147] 0 0
Lancashire
Country [148] 0 0
United Kingdom
State/province [148] 0 0
Middlesex
Country [149] 0 0
United Kingdom
State/province [149] 0 0
Surrey
Country [150] 0 0
United Kingdom
State/province [150] 0 0
West Midlands
Country [151] 0 0
United Kingdom
State/province [151] 0 0
Huddersfield
Country [152] 0 0
United Kingdom
State/province [152] 0 0
London
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Sheffield

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


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/NCT00073528