Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD)

NCT00400153 | Completed Phase 3 Results

• 1 other identifier: 1012.56
• Study Type: interventional
• Target: 1,480
• Locations: 13 countries
• Sites: 180

Brief Summary

The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (3)

• FEV1 AUC0-6 at Day 85

  Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 6 hours divided by 6 at Day 85

  Before drug administration to 6 hours after drug administration on Day 85

• FEV1 AUC0-4 at Day 85

  Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 0 to 4 hours divided by 4 at Day 85

  Before drug administration to 4 hours after drug administration on Day 85

• FEV1 AUC4-6 at Day 85

  Area between the test-day baseline FEV1 and the FEV1 change from the test-day baseline curve from 4 to 6 hours divided by 2 at Day 85

  Between 4 hours and 6 hours after drug administration on Day 85

Secondary Outcomes (75)

• FEV1 AUC0-6 at Day 1

  Before drug administration to 6 hours after drug administration on Day 1

• FEV1 AUC0-6 at Day 29

  Before drug administration to 6 hours after drug administration on Day 29

• FEV1 AUC0-6 at Day 57

  Before drug administration to 6 hours after drug administration on Day 57

• FEV1 AUC0-4 at Day 1

  Before drug administration to 4 hours after drug administration on Day 1

• FEV1 AUC0-4 at Day 29

  Before drug administration to 4 hours after drug administration on Day 29

Study Arms (3)

COMBIVENT Respimat 20/100 mcg

EXPERIMENTAL

Drug: Combivent Respimat (20 mcg/100 mcg); Drug: Placebo via corresponding inhaler for blinding purposes

COMBIVENT CFC-MDI 36/206 mcg

EXPERIMENTAL

Drug: COMBIVENT MDI (36/206 mcg); Drug: Placebo via corresponding inhaler for blinding purposes

Ipratropium Respimat 20 mcg

EXPERIMENTAL

Drug: Atrovent Respimat (20 mcg); Drug: Placebo via corresponding inhaler for blinding purposes

Interventions

Atrovent Respimat (20 mcg) DRUG

Ipratropium Respimat 20 mcg

COMBIVENT MDI (36/206 mcg) DRUG

COMBIVENT CFC-MDI 36/206 mcg

Combivent Respimat (20 mcg/100 mcg) DRUG

COMBIVENT Respimat 20/100 mcg

Placebo via corresponding inhaler for blinding purposes DRUG

COMBIVENT CFC-MDI 36/206 mcg; COMBIVENT Respimat 20/100 mcg; Ipratropium Respimat 20 mcg

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Outpatients of either sex, 40 years or older, with a diagnosis of COPD (FEV1 65% predicted normal and FEV1/FVC 70%).

You may not qualify if:

• Patients with significant diseases other than COPD that may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study, with a history of asthma or allergic rhinitis, who regularly use daytime oxygen therapy for more than 1 hour per day and in the investigator's opinion will be unable to abstain from the use of oxygen therapy or using oral corticosteroid me dication at unstable doses (i.e., less than 6 weeks on a stable dose) or at a dose in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day will be excluded.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (180)

1012.56.01006 Boehringer Ingelheim Investigational Site

Birmingham, Alabama, United States

Location

1012.56.01051 Boehringer Ingelheim Investigational Site

Jasper, Alabama, United States

Location

1012.56.01071 Boehringer Ingelheim Investigational Site

Mobile, Alabama, United States

Location

1012.56.01039 Boehringer Ingelheim Investigational Site

Phoenix, Arizona, United States

Location

1012.56.01012 Boehringer Ingelheim Investigational Site

Lakewood, California, United States

Location

1012.56.01029 Boehringer Ingelheim Investigational Site

Los Angeles, California, United States

Location

1012.56.01043 Boehringer Ingelheim Investigational Site

Palo Alto, California, United States

Location

1012.56.01089 Boehringer Ingelheim Investigational Site

Rancho Mirage, California, United States

Location

1012.56.01021 Boehringer Ingelheim Investigational Site

Riverside, California, United States

Location

1012.56.01033 Boehringer Ingelheim Investigational Site

San Jose, California, United States

Location

1012.56.01020 Boehringer Ingelheim Investigational Site

Sepulveda, California, United States

Location

1012.56.01045 Boehringer Ingelheim Investigational Site

Torrence, California, United States

Location

1012.56.01040 Boehringer Ingelheim Investigational Site

Denver, Colorado, United States

Location

1012.56.01050 Boehringer Ingelheim Investigational Site

Fort Collins, Colorado, United States

Location

1012.56.01018 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1012.56.01062 Boehringer Ingelheim Investigational Site

Wheat Ridge, Colorado, United States

Location

1012.56.01036 Boehringer Ingelheim Investigational Site

Hartford, Connecticut, United States

Location

1012.56.01025 Boehringer Ingelheim Investigational Site

Stamford, Connecticut, United States

Location

1012.56.01088 Boehringer Ingelheim Investigational Site

Waterbury, Connecticut, United States

Location

1012.56.01007 Boehringer Ingelheim Investigational Site

Bay Pines, Florida, United States

Location

1012.56.01058 Boehringer Ingelheim Investigational Site

Brandon, Florida, United States

Location

1012.56.01010 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1012.56.01065 Boehringer Ingelheim Investigational Site

Clearwater, Florida, United States

Location

1012.56.01024 Boehringer Ingelheim Investigational Site

DeLand, Florida, United States

Location

1012.56.01001 Boehringer Ingelheim Investigational Site

Melbourne, Florida, United States

Location

1012.56.01023 Boehringer Ingelheim Investigational Site

Panama City, Florida, United States

Location

1012.56.01052 Boehringer Ingelheim Investigational Site

Pensecola, Florida, United States

Location

1012.56.01048 Boehringer Ingelheim Investigational Site

Tampa, Florida, United States

Location

1012.56.01093 Boehringer Ingelheim Investigational Site

Winter Park, Florida, United States

Location

1012.56.01077 Boehringer Ingelheim Investigational Site

Atlanta, Georgia, United States

Location

1012.56.01083 Boehringer Ingelheim Investigational Site

Decatur, Georgia, United States

Location

1012.56.01008 Boehringer Ingelheim Investigational Site

Coeur d'Alene, Idaho, United States

Location

1012.56.01019 Boehringer Ingelheim Investigational Site

Olathe, Kansas, United States

Location

1012.56.01056 Boehringer Ingelheim Investigational Site

Wichita, Kansas, United States

Location

1012.56.01066 Boehringer Ingelheim Investigational Site

Bowling Green, Kentucky, United States

Location

1012.56.01090 Boehringer Ingelheim Investigational Site

Lafayette, Louisiana, United States

Location

1012.56.01054 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

1012.56.01072 Boehringer Ingelheim Investigational Site

New Orleans, Louisiana, United States

Location

1012.56.01070 Boehringer Ingelheim Investigational Site

Shreveport, Louisiana, United States

Location

1012.56.01035 Boehringer Ingelheim Investigational Site

Baltimore, Maryland, United States

Location

1012.56.01079 Boehringer Ingelheim Investigational Site

Ann Arbor, Michigan, United States

Location

1012.56.01044 Boehringer Ingelheim Investigational Site

Minneapolis, Minnesota, United States

Location

1012.56.01076 Boehringer Ingelheim Investigational Site

St Louis, Missouri, United States

Location

1012.56.01082 Boehringer Ingelheim Investigational Site

Henderson, Nevada, United States

Location

1012.56.01049 Boehringer Ingelheim Investigational Site

Reno, Nevada, United States

Location

1012.56.01080 Boehringer Ingelheim Investigational Site

Brick, New Jersey, United States

Location

1012.56.01027 Boehringer Ingelheim Investigational Site

Cherry Hill, New Jersey, United States

Location

1012.56.01028 Boehringer Ingelheim Investigational Site

Summit, New Jersey, United States

Location

1012.56.01069 Boehringer Ingelheim Investigational Site

Albuquerque, New Mexico, United States

Location

1012.56.01022 Boehringer Ingelheim Investigational Site

Larchmont, New York, United States

Location

1012.56.01015 Boehringer Ingelheim Investigational Site

New Hyde Park, New York, United States

Location

1012.56.01068 Boehringer Ingelheim Investigational Site

New York, New York, United States

Location

1012.56.01078 Boehringer Ingelheim Investigational Site

Asheville, North Carolina, United States

Location

1012.56.01017 Boehringer Ingelheim Investigational Site

Raleigh, North Carolina, United States

Location

1012.56.01042 Boehringer Ingelheim Investigational Site

Winston-Salem, North Carolina, United States

Location

1012.56.01034 Boehringer Ingelheim Investigational Site

Sylvania, Ohio, United States

Location

1012.56.01031 Boehringer Ingelheim Investigational Site

Toledo, Ohio, United States

Location

1012.56.01038 Boehringer Ingelheim Investigational Site

Oklahoma City, Oklahoma, United States

Location

1012.56.01016 Boehringer Ingelheim Investigational Site

Medford, Oregon, United States

Location

1012.56.01067 Boehringer Ingelheim Investigational Site

Hershey, Pennsylvania, United States

Location

1012.56.01003 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1012.56.01060 Boehringer Ingelheim Investigational Site

Philadelphia, Pennsylvania, United States

Location

1012.56.01004 Boehringer Ingelheim Investigational Site

Pittsburgh, Pennsylvania, United States

Location

1012.56.01087 Boehringer Ingelheim Investigational Site

East Providence, Rhode Island, United States

Location

1012.56.01057 Boehringer Ingelheim Investigational Site

Johnston, Rhode Island, United States

Location

1012.56.01026 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1012.56.01037 Boehringer Ingelheim Investigational Site

Charleston, South Carolina, United States

Location

1012.56.01081 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1012.56.01085 Boehringer Ingelheim Investigational Site

Greenville, South Carolina, United States

Location

1012.56.01084 Boehringer Ingelheim Investigational Site

Greer, South Carolina, United States

Location

1012.56.01011 Boehringer Ingelheim Investigational Site

Spartanburg, South Carolina, United States

Location

1012.56.01073 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

1012.56.01075 Boehringer Ingelheim Investigational Site

Nashville, Tennessee, United States

Location

1012.56.01047 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

1012.56.01014 Boehringer Ingelheim Investigational Site

Houston, Texas, United States

Location

1012.56.01032 Boehringer Ingelheim Investigational Site

Killeen, Texas, United States

Location

1012.56.01002 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1012.56.01053 Boehringer Ingelheim Investigational Site

San Antonio, Texas, United States

Location

1012.56.01009 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1012.56.01013 Boehringer Ingelheim Investigational Site

Richmond, Virginia, United States

Location

1012.56.01059 Boehringer Ingelheim Investigational Site

Roanoke, Virginia, United States

Location

1012.56.01055 Boehringer Ingelheim Investigational Site

Salem, Virginia, United States

Location

1012.56.01063 Boehringer Ingelheim Investigational Site

Bellington, Washington, United States

Location

1012.56.01005 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1012.56.01064 Boehringer Ingelheim Investigational Site

Spokane, Washington, United States

Location

1012.56.01030 Boehringer Ingelheim Investigational Site

Tacoma, Washington, United States

Location

1012.56.01074 Boehringer Ingelheim Investigational Site

Morgantown, West Virginia, United States

Location

1012.56.54001 Centro Médico de la Dra. De Salvo

Capital Federal, Argentina

Location

1012.56.54002 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1012.56.54003 Policlínica Bancaria

Capital Federal, Argentina

Location

1012.56.54004 Hospital Ramos Mejia

Capital Federal, Argentina

Location

1012.56.54010 Instituto Lanari

Capital Federal, Argentina

Location

1012.56.54011 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1012.56.54015 Boehringer Ingelheim Investigational Site

Capital Federal, Argentina

Location

1012.56.54005 Instituto de Diagnóstico Cardiovascular La Plata

La Plata, Argentina

Location

1012.56.54012 Boehringer Ingelheim Investigational Site

Lanús, Argentina

Location

1012.56.54009 Instituto de Investigaciones Clínicas

Mar del Plata, Argentina

Location

1012.56.54014 Boehringer Ingelheim Investigational Site

Mendoza, Argentina

Location

1012.56.54007 CLINICA PRIVADA de MONTE GRANDE

Monte Grande, Argentina

Location

1012.56.54006 CENTRO PRIVADO de MEDICINA RESPIRATORIA

Paraná, Argentina

Location

1012.56.54008 HOSPITAL ITALIANO de ROSARIO

Rosario, Argentina

Location

1012.56.54013 Boehringer Ingelheim Investigational Site

San Miguel de Tucumán, Argentina

Location

1012.56.3305A Centre hospitalier Germon & Gauthier

Béthune, France

Location

1012.56.3303A Clinique de la Louvière

Lille, France

Location

1012.56.3301A Hôpital Ambroise Paré

Marseille, France

Location

1012.56.3304A Centre Médical Erdre Saint Augustin

Nantes, France

Location

1012.56.3302A Cabinet Médical

Nice, France

Location

1012.56.3302B Cabinet Médical

Nice, France

Location

1012.56.30001 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1012.56.30011 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1012.56.30013 Boehringer Ingelheim Investigational Site

Athens, Greece

Location

1012.56.30010 Boehringer Ingelheim Investigational Site

Corinth, Greece

Location

1012.56.30009 Boehringer Ingelheim Investigational Site

Heraklion, Greece

Location

1012.56.30007 Boehringer Ingelheim Investigational Site

Komotini, Greece

Location

1012.56.30002 Boehringer Ingelheim Investigational Site

Larissa, Greece

Location

1012.56.30014 Boehringer Ingelheim Investigational Site

Nafplion, Greece

Location

1012.56.30003 Boehringer Ingelheim Investigational Site

Thessaloniki, Greece

Location

1012.56.64004 Boehringer Ingelheim Investigational Site

Dunedin, New Zealand

Location

1012.56.64001 Boehringer Ingelheim Investigational Site

Grafton / Auckland, New Zealand

Location

1012.56.64003 Boehringer Ingelheim Investigational Site

Hamilton, New Zealand

Location

1012.56.64006 Boehringer Ingelheim Investigational Site

Tauranga, New Zealand

Location

1012.56.64005 Boehringer Ingelheim Investigational Site

Wellington, New Zealand

Location

1012.56.48009 Boehringer Ingelheim Investigational Site

Bydgoszcz, Poland

Location

1012.56.48006 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1012.56.48007 Boehringer Ingelheim Investigational Site

Krakow, Poland

Location

1012.56.48004 Boehringer Ingelheim Investigational Site

Ostrow Wielkopolska, Poland

Location

1012.56.48005 Boehringer Ingelheim Investigational Site

Poznan, Poland

Location

1012.56.48002 Boehringer Ingelheim Investigational Site

Proszowice, Poland

Location

1012.56.48010 Boehringer Ingelheim Investigational Site

Radom, Poland

Location

1012.56.48001 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1012.56.48011 Boehringer Ingelheim Investigational Site

Warsaw, Poland

Location

1012.56.48003 Boehringer Ingelheim Investigational Site

Wroclaw, Poland

Location

1012.56.07010 Boehringer Ingelheim Investigational Site

Kazan', Russia

Location

1012.56.07001 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1012.56.07002 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1012.56.07003 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1012.56.07005 Boehringer Ingelheim Investigational Site

Moscow, Russia

Location

1012.56.07007 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1012.56.07008 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1012.56.07009 Boehringer Ingelheim Investigational Site

Saint Petersburg, Russia

Location

1012.56.27002 Boehringer Ingelheim Investigational Site

Bellville, South Africa

Location

1012.56.27008 Boehringer Ingelheim Investigational Site

Boksburg, South Africa

Location

1012.56.27001 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1012.56.27004 Boehringer Ingelheim Investigational Site

Cape Town, South Africa

Location

1012.56.27005 Boehringer Ingelheim Investigational Site

Johannesburg, South Africa

Location

1012.56.27009 Boehringer Ingelheim Investigational Site

Orange Grove, South Africa

Location

1012.56.27003 Boehringer Ingelheim Investigational Site

Paarl, South Africa

Location

1012.56.27006 Boehringer Ingelheim Investigational Site

Park Town West, South Africa

Location

1012.56.82009 Boehringer Ingelheim Investigational Site

Daegu, South Korea

Location

1012.56.82010 Boehringer Ingelheim Investigational Site

Geonggi-Do, South Korea

Location

1012.56.82008 Boehringer Ingelheim Investigational Site

Gyeonggi-do, South Korea

Location

1012.56.82001 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1012.56.82002 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1012.56.82005 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1012.56.82006 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1012.56.82007 Boehringer Ingelheim Investigational Site

Seoul, South Korea

Location

1012.56.88604 Chang Gong Memorial Hospital

Keelong Town, Taiwan

Location

1012.56.88605 Taichung Veterans General Hospital

Taichung, Taiwan

Location

1012.56.88602 Taipei Veterans General Hospital

Taipei, Taiwan

Location

1012.56.88603 National Taiwan University Hospital

Taipei, Taiwan

Location

1012.56.88601 Chang Gung Memorial Hosp-Linkou

Taoyuan District, Taiwan

Location

1012.56.90001 Boehringer Ingelheim Investigational Site

Ankara, Turkey (Türkiye)

Location

1012.56.90005 Boehringer Ingelheim Investigational Site

Antalya, Turkey (Türkiye)

Location

1012.56.90003 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1012.56.90006 Boehringer Ingelheim Investigational Site

Istanbul, Turkey (Türkiye)

Location

1012.56.90002 Boehringer Ingelheim Investigational Site

Mersin, Turkey (Türkiye)

Location

1012.56.38005 Boehringer Ingelheim Investigational Site

Dnyepropyetrovsk, Ukraine

Location

1012.56.38006 Boehringer Ingelheim Investigational Site

Donetsk, Ukraine

Location

1012.56.38001 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1012.56.38002 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1012.56.38004 Boehringer Ingelheim Investigational Site

Kiev, Ukraine

Location

1012.56.44009 Boehringer Ingelheim Investigational Site

Ballieston, Glasgow, United Kingdom

Location

1012.56.44003 Boehringer Ingelheim Investigational Site

Bury Saint Edmonds, United Kingdom

Location

1012.56.44002 Boehringer Ingelheim Investigational Site

Cambridge, United Kingdom

Location

1012.56.44006 Colchester General Hospital

Colchester, United Kingdom

Location

1012.56.44007 Boehringer Ingelheim Investigational Site

Doncaster, United Kingdom

Location

1012.56.44001 Medicine Evaluation Unit

Manchester, United Kingdom

Location

1012.56.44008 The Staploe Medical Centre

Soham, United Kingdom

Location

1012.56.44005 Morriston Hospital

Swansea, United Kingdom

Location

1012.56.44010 Boehringer Ingelheim Investigational Site

Windsor, United Kingdom

Location

Related Publications (1)

• Zuwallack R, De Salvo MC, Kaelin T, Bateman ED, Park CS, Abrahams R, Fakih F, Sachs P, Pudi K, Zhao Y, Wood CC; Combivent Respimat Inhaler Study Group. Efficacy and safety of ipratropium bromide/albuterol delivered via Respimat inhaler versus MDI. Respir Med. 2010 Aug;104(8):1179-88. doi: 10.1016/j.rmed.2010.01.017. Epub 2010 Feb 20.

  PMID: 20172704 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Albuterol, Ipratropium Drug Combination

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Ipratropium; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring; Drug Combinations; Pharmaceutical Preparations

Limitations and Caveats

The FEV1 and FVC measurements at each observation time point were used to derive the primary and secondary efficacy endpoints and are not reported here. All statistical analyses for secondary endpoints are exploratory and the p-values are nominal.

Results Point of Contact

• Title: Boehringer Ingelheim Pharmaceuticals
• Organization: Boehringer Ingelheim Pharmaceuticals

clintriage.rdg@boehringer-ingelheim.com

800-542-6257 Option 4

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 15, 2006
• First Posted: November 16, 2006
• Study Start: November 1, 2006
• Primary Completion: April 1, 2008
• Last Updated: June 13, 2014
• Results First Posted: June 1, 2009

Record last verified: 2014-06

Locations

UA (5); NZ (5); ZA (8); KR (8); TU (5); GB (9); AR (15); US (87); TW (5); FR (6); GR (9); RU (8); PL (10)