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Spiriva® Assessment of FEV1 (SAFE)

Primary Purpose

Pulmonary Disease, Chronic Obstructive

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Tiotropium (Spiriva®)
Sponsored by
Boehringer Ingelheim
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Disease, Chronic Obstructive

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Diagnosis of COPD Stable airway obstruction FEV1 < or equal to 65% of predicted Male or female Age > or equal to 40 years > or equal to 10 pack year smoking history History of exacerbations in the past year Able to be trained in the proper use of the HandiHaler® Exclusion Criteria: History of asthma Allergic rhinitis or atopy Unstable use (6 weeks) of OCS (or > 10 mg daily use) History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis Patients who had started or stopped an exercise rehabilitation program in the past twelve months Thoracotomy with pulmonary resection or lobectomy (LVRS) Active tuberculosis Use of beta-blockers Pregnant, nursing women and women of childbearing potential not using a medically approved means of contraception 6 months or less history of myocardial infarction Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system History of unstable arrhythmia with a life threatening event or change of related therapy during the past year History of cancer, other than treated basal cell carcinoma, within the last 12 months Clinically relevant abnormal baseline haematology, blood chemistry or urinalysis Patients with narrow angle glaucoma Patients with symptomatic benign prostatic hypertrophy Patients with bladder neck obstruction Patients that planned to be out of the country for 8 weeks or more

Sites / Locations

  • Respiratory Research, Room 1742
  • Boehringer Ingelheim Investigational Site
  • 4A-185, 7007-14 Street SW
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 301-131 First Ave.
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 220 Royal Avenue
  • Penticton Regional Hospital
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 1095 Concordia Avenue
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 262 Newfoundland Drive
  • 300 Prince Philip Drive
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 169 Main Street East
  • 237 Barton Street East
  • HGH McMaster Clinic
  • Boehringer Ingelheim Investigational Site
  • 50 Charlton Avenue East
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Haemolology Division
  • St Joseph's Healthcare
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 300-2338 Hurontario Street
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Ottawa Hospital - General Campus
  • 1053 Carling Avenue
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 825 Coxwell Avenue
  • Boehringer Ingelheim Investigational Site
  • 600 Sherbourne Street, Suite 402
  • Boehringer Ingelheim Investigational Site
  • Toronto General Hospital
  • 76 Grenville Street
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 91 Thomas-Chapais
  • 305 rue Saint-Vallier
  • Boehringer Ingelheim Investigational Site
  • 4 rue Robinson
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 2180 rue Fleury E
  • UHRESS, Pavillon L-C Simard, 10th Floor, Z10904
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Hop du Sacre-Coeur de Montreal
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 3001 12e ave Nord
  • Boehringer Ingelheim Investigational Site
  • Hopital Laval
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • Boehringer Ingelheim Investigational Site
  • 1401-18 Rue

Outcomes

Primary Outcome Measures

The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment.

Secondary Outcome Measures

The change from baseline FEV1 at interim visits
The change from baseline FVC
The change from baseline FEV6 (at selected sites)
Incidence, severity and duration of COPD exacerbations
Incidence and duration of hospitalisations due to COPD exacerbations
Use of rescue medication (day-time and night-time) during treatment period
Number of short courses of steroids/antibiotics during treatment period
Assessment of COPD symptoms
Physician's Global Evaluation
Quality of life questionnaire (SGRQ)
Adverse events
Vital Signs

Full Information

First Posted
January 9, 2006
Last Updated
November 5, 2013
Sponsor
Boehringer Ingelheim
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1. Study Identification

Unique Protocol Identification Number
NCT00277264
Brief Title
Spiriva® Assessment of FEV1 (SAFE)
Official Title
Spiriva® Assessment of FEV1 (SAFE). The Effect of Inhaled Tiotropium Bromide (18 Mcg Once Daily) on the Change in FEV1 During Long-term Treatment in Patients With COPD. A One-year Parallel Group, Double-blind, Randomised, Placebo-controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Completed
Study Start Date
January 2002 (undefined)
Primary Completion Date
May 2004 (Actual)
Study Completion Date
May 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Boehringer Ingelheim

4. Oversight

5. Study Description

Brief Summary
The objective of this trial is to evaluate whether the effect of one year (48 weeks) treatment with inhaled tiotropium bromide (Spiriva® - 18 µg once daily) on the change in trough FEV1, compared to placebo in patients with COPD, is affected by smoking status.
Detailed Description
This was a multi-centre, randomised, double-blind, placebo-controlled study. The duration of subject participation was 48 weeks. There was an initial screening period of up to 2 weeks. The first screening visit consisted of medical history, clinical assessment, safety laboratory assessments and complete pulmonary function testing. The screening period was followed by a randomised treatment period where patients received tiotropium (Spiriva) or placebo in a ratio of 2:1. During the treatment period there were a total of 5 clinic visits (including randomisation and EOT visit). Each visit included lung function measurements and clinical assessments (SQRQ, COPD Symptom scores, physician's global assessment, COPD exacerbations/hospitalisations, vital signs and rescue medication use) in addition to adverse event reporting. The final visit consisted of a telephone contact 2 weeks after the patient completed their trial medication. Study Hypothesis: The primary purpose of this trial was to evaluate whether the effect of inhaled tiotropium (Spiriva®) on the change in trough FEV1, compared to placebo, was affected by smoking status. The primary endpoint was defined as the change in trough FEV1 after 48 weeks of treatment. The primary analysis was performed in a sequential fashion; firstly, the analysis was performed for all patients and if a positive signal was seen in this group, the analysis was then performed for both the smoking and ex-smoking groups separately. Patients were defined as smokers or ex-smokers at the screening visit. Comparison(s): Tiotropium (Spiriva®) vs placebo

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Disease, Chronic Obstructive

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
914 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Tiotropium (Spiriva®)
Primary Outcome Measure Information:
Title
The primary efficacy endpoint was the change in trough FEV1 after 48 weeks of treatment.
Time Frame
after 48 weeks of treatment
Secondary Outcome Measure Information:
Title
The change from baseline FEV1 at interim visits
Time Frame
at Week 2, 11, 30 and 48
Title
The change from baseline FVC
Time Frame
at Week 2, 11, 30 and 48
Title
The change from baseline FEV6 (at selected sites)
Time Frame
at Week 2, 11, 30 and 48
Title
Incidence, severity and duration of COPD exacerbations
Time Frame
at Week 2, 11, 30, 48 and 50
Title
Incidence and duration of hospitalisations due to COPD exacerbations
Time Frame
at Week 2, 11, 30, 48 and 50
Title
Use of rescue medication (day-time and night-time) during treatment period
Time Frame
week 1 until week 48
Title
Number of short courses of steroids/antibiotics during treatment period
Time Frame
week 1 until week 48
Title
Assessment of COPD symptoms
Time Frame
at Week 2, 11, 30 and 48
Title
Physician's Global Evaluation
Time Frame
baseline and week 48
Title
Quality of life questionnaire (SGRQ)
Time Frame
at week 30 and 48
Title
Adverse events
Time Frame
27 months
Title
Vital Signs
Time Frame
27 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of COPD Stable airway obstruction FEV1 < or equal to 65% of predicted Male or female Age > or equal to 40 years > or equal to 10 pack year smoking history History of exacerbations in the past year Able to be trained in the proper use of the HandiHaler® Exclusion Criteria: History of asthma Allergic rhinitis or atopy Unstable use (6 weeks) of OCS (or > 10 mg daily use) History of life threatening bronchial obstruction, cystic fibrosis or bronchiectasis Patients who had started or stopped an exercise rehabilitation program in the past twelve months Thoracotomy with pulmonary resection or lobectomy (LVRS) Active tuberculosis Use of beta-blockers Pregnant, nursing women and women of childbearing potential not using a medically approved means of contraception 6 months or less history of myocardial infarction Intolerance to anticholinergic containing products, and/or to lactose or any other components of the inhalation capsule delivery system History of unstable arrhythmia with a life threatening event or change of related therapy during the past year History of cancer, other than treated basal cell carcinoma, within the last 12 months Clinically relevant abnormal baseline haematology, blood chemistry or urinalysis Patients with narrow angle glaucoma Patients with symptomatic benign prostatic hypertrophy Patients with bladder neck obstruction Patients that planned to be out of the country for 8 weeks or more
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Boehringer Ingelheim Study Coordinator
Organizational Affiliation
B.I. Canada Ltd.
Official's Role
Study Chair
Facility Information:
Facility Name
Respiratory Research, Room 1742
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N1
Country
Canada
Facility Name
4A-185, 7007-14 Street SW
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2V 1P9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5G 3G6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Lethbridge
State/Province
Alberta
ZIP/Postal Code
T1J 0Z2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Medicine Hat
State/Province
Alberta
ZIP/Postal Code
T1A 4E4
Country
Canada
Facility Name
301-131 First Ave.
City
Spruce Grove
State/Province
Alberta
ZIP/Postal Code
T7X 2Z8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Wetaskiwin
State/Province
Alberta
ZIP/Postal Code
T9A 3N3
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Abbotsford
State/Province
British Columbia
ZIP/Postal Code
V2S 6R6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Chilliwack
State/Province
British Columbia
ZIP/Postal Code
V2P 4M9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1W 3T1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Maple Ridge
State/Province
British Columbia
ZIP/Postal Code
V2X 2L5
Country
Canada
Facility Name
220 Royal Avenue
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 1H6
Country
Canada
Facility Name
Penticton Regional Hospital
City
Penticton
State/Province
British Columbia
ZIP/Postal Code
V2A 3G6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3V 1N1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 3J5
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z !Y6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Victoria
State/Province
British Columbia
ZIP/Postal Code
V8R 6V4
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Steinbach
State/Province
Manitoba
ZIP/Postal Code
R0A 2T3
Country
Canada
Facility Name
1095 Concordia Avenue
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R2K 3S8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saint John
State/Province
New Brunswick
ZIP/Postal Code
E2M 3W5
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Mount Pearl
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1N 2C3
Country
Canada
Facility Name
262 Newfoundland Drive
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1A 3R5
Country
Canada
Facility Name
300 Prince Philip Drive
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
New Glasgow
State/Province
Nova Scotia
ZIP/Postal Code
B2H 1K1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Sydney
State/Province
Nova Scotia
ZIP/Postal Code
B1P 1P3
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Ajax
State/Province
Ontario
ZIP/Postal Code
L1S 2J5
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Corunna
State/Province
Ontario
ZIP/Postal Code
N0N 1G0
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Courtice
State/Province
Ontario
ZIP/Postal Code
L1E 3C3
Country
Canada
Facility Name
169 Main Street East
City
Grimsby
State/Province
Ontario
ZIP/Postal Code
L3M 1P3
Country
Canada
Facility Name
237 Barton Street East
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
HGH McMaster Clinic
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8L 2X2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8M 1K7
Country
Canada
Facility Name
50 Charlton Avenue East
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8V 1C1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L 5E4
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Kitchener
State/Province
Ontario
ZIP/Postal Code
N2C 2N9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N5W 6A2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
Haemolology Division
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4G5
Country
Canada
Facility Name
St Joseph's Healthcare
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4V2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5R9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Markham
State/Province
Ontario
ZIP/Postal Code
L6B 1A1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 1N2
Country
Canada
Facility Name
300-2338 Hurontario Street
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5B 1N1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Mississauga
State/Province
Ontario
ZIP/Postal Code
L5M 2V8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Niagara Falls
State/Province
Ontario
ZIP/Postal Code
L2G 1J4
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2K 2W2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
North York
State/Province
Ontario
ZIP/Postal Code
M2K 2Z3
Country
Canada
Facility Name
Ottawa Hospital - General Campus
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L6
Country
Canada
Facility Name
1053 Carling Avenue
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4G2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4P6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Peterborough
State/Province
Ontario
ZIP/Postal Code
K9J 7H8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Richmond Hill
State/Province
Ontario
ZIP/Postal Code
L4C 2N9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Scarborough
State/Province
Ontario
ZIP/Postal Code
M1B 4Z8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Thunder Bay
State/Province
Ontario
ZIP/Postal Code
P7E 1G6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1P 2T3
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1S 4V5
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M1W 2R6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3C 3G8
Country
Canada
Facility Name
825 Coxwell Avenue
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4C 3E7
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4M 1J5
Country
Canada
Facility Name
600 Sherbourne Street, Suite 402
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4X 1W4
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1E2
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
76 Grenville Street
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1B2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Trenton
State/Province
Ontario
ZIP/Postal Code
K8V 6H9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N9A 1C9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
York
State/Province
Ontario
ZIP/Postal Code
M9N 1J4
Country
Canada
Facility Name
91 Thomas-Chapais
City
Boucherville
State/Province
Quebec
ZIP/Postal Code
J4B 6P3
Country
Canada
Facility Name
305 rue Saint-Vallier
City
Chicoutimi
State/Province
Quebec
ZIP/Postal Code
G7H 5H6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8P 7H2
Country
Canada
Facility Name
4 rue Robinson
City
Granby
State/Province
Quebec
ZIP/Postal Code
J2G 8Z9
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2G8
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
La Malbaie
State/Province
Quebec
ZIP/Postal Code
G5A 1W7
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Laval
State/Province
Quebec
ZIP/Postal Code
H7V 3Y7
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V 1X4
Country
Canada
Facility Name
2180 rue Fleury E
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2B 1K3
Country
Canada
Facility Name
UHRESS, Pavillon L-C Simard, 10th Floor, Z10904
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3H 1V4
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
Facility Name
Hop du Sacre-Coeur de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4J 1C5
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4N 2W2
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Pointe Claire
State/Province
Quebec
ZIP/Postal Code
H9R 4S3
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saint Jerome
State/Province
Quebec
ZIP/Postal Code
J7Z 5T3
Country
Canada
Facility Name
3001 12e ave Nord
City
Sherbrooke
State/Province
Quebec
ZIP/Postal Code
J1H 5N4
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
St-Jean Richelieu
State/Province
Quebec
ZIP/Postal Code
J3A 1C3
Country
Canada
Facility Name
Hopital Laval
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7H 5M3
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0H6
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 3H3
Country
Canada
Facility Name
Boehringer Ingelheim Investigational Site
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7L 2W1
Country
Canada
Facility Name
1401-18 Rue
City
Quebec
ZIP/Postal Code
G1J 1Z4
Country
Canada

12. IPD Sharing Statement

Links:
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.259_U05-3345.pdf
Description
Related Info
URL
http://trials.boehringer-ingelheim.com/content/dam/internet/opu/clinicaltrial/com_EN/results/205/205.259_literature.pdf
Description
Related Info

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