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Sponsored by: |
Boehringer Ingelheim Pharmaceuticals |
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Information provided by: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00514683 |
The general purpose of this trial is to investigate the efficacy and safety of 4 dose strategies of BIBF 1120 treatment for 12 months, compared to placebo in patients with idiopathic pulmonary fibrosis.
The primary objective of this study is to demonstrate whether at least one dose strategy is superior to placebo in patients with IPF, in modifying the rate of decline of Forced Vital Capacity (FVC).
As a secondary objective, additional parameters will be assessed in order to differentiate between dose strategies on the basis of safety and efficacy
Condition | Intervention | Phase |
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Pulmonary Fibrosis |
Drug: BIBF1120 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A 12 Month, Double Blind, Randomized, Placebo-controlled Trial Evaluating the Effect of BIBF 1120 Administered at Oral Doses of 50 mg qd, 50 mg Bid, 100 mg Bid and 150 mg Bid on Forced Vital Capacity Decline During One Year, in Patients With Idiopathic Pulmonary Fibrosis, With Optional Active Treatment Extension Until Last Patient Out. |
Estimated Enrollment: | 432 |
Study Start Date: | August 2007 |
Estimated Primary Completion Date: | June 2010 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 40 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
FVC>50 % of predicted value
Predicted normal values will be calculated according to ESCS (R94-1408):
Males :
FVC predicted (L) = 5.76 x height (meters)- 0.026 x age (years) -4.34
Females :
FVC predicted (L) = 4.43 x height (meters)- 0.026 x age (years) -2.89
Single breath DLCO (corrected for Hb) 30 - 79% inclusive of predicted .
Different sites may use different prediction formulas, based on the method used to measure DLco. In any case, the method used must be in compliance with the ATS/ERS guideline on DLCO measurements (R06-2002), and the prediction formula appropriate for that method. Raw data (gas mixture, equation used for prediction of normal, further adjustments made if so) must be traced.
Adjustment for haemoglobin (R06-2002):
Males :
DLCO predicted for Hb = DLCO predicted x (1.7Hb/[10.22+Hb])
Females :
DLCO predicted for Hb = DLCO predicted x (1.7Hb/[9.38+Hb]) where Hb is expressed in g/dL-1
Exclusion Criteria:
International normalised ratio (INR) > 1.5 and/or Partial thromboplastin time (PTT) > 1.5 x ULN
;
Other disease that may interfere with testing procedures or in judgement of Investigator may interfere with trial participation or may put the patient at risk when participating to this trial.
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
Responsible Party: | Boehringer Ingelheim ( Boehringer Ingelheim, Study Chair ) |
Study ID Numbers: | 1199.30 |
Study First Received: | August 9, 2007 |
Last Updated: | August 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00514683 History of Changes |
Health Authority: | Argentina: A.N.M.A.T. (Administración Nacional de Medicamentos, Alimentos y Tecnologia Médica); Australia: Responsilble Ethics Committee; Belgium: Federal Agency for Medicines and Health Products; Brazil: ANVISA; Bulgaria: Bulgarian Drug Agency, BG-1504 Sofia; Canada: Therapeutic Products Directorate; Chile: Instituto de Salud Publica de Chile; China: State Food and Drug Administration; Czech Republic: State Institute for Drug Control (SUKL), CZ-100 41 Prague 10; France: AGENCE FRANCAISE DE SECURITE SANITAIRE DES PRODUITS DE SANTE; Germany: Bundesinstitut für Arzneimittel und Medizinprodukte, Fachregistratur Z 14.02.06, Kurt-Georg-Kiesinger-Allee 3, 53175 Bonn; Great Britain: MHRA; Greece: National Organization for Medicines (EOF) National Ethics Committee; Hungary: National Institute of Pharmacy, H-1051 Budapest; Ireland: Irish Medicines Board; Italy: Comitato Etico Provinciale di Modena - MODENA; Korea, Republic of: Korea Food and Drug Administration (KFDA); Mexico: Federal Commission for Protection Against Health Risks; Netherlands: The Central Committee on Research Involving Human Subjects (CCMO); Portugal: INFARMED - Autoridade Nacional do Medicamento e Produtos de Saúde, I.P. Parque de Saúde de Lisboa - Avenida do Brasil, 53 1749-004 Lisboa - Portugal; Russia: Ministry of Healthcare and Social Development of Russian Federation, Moscow; South Africa: Medicines Control Council; Spain: Spanish Agency for Medicines and Health Products; Taiwan: Department of Health, Executive Yuan, Taiwan; Turkey: Ministry of Health Central Ethics Committee |
Lung Diseases, Interstitial Respiratory Tract Diseases Fibrosis |
Idiopathic Pulmonary Fibrosis Lung Diseases Pulmonary Fibrosis |
Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases |
Fibrosis Lung Diseases Pulmonary Fibrosis |