Contents of the clinical dossier of the clinical dossier The clinical dossier documented a development program of pharmacology, efficacy and safety studies relating to the proposed extension of indications. The submission contained the following clinical information: Ten clinical pharmacology studies, including six that provided pharmacokinetic data and six that provided pharmacodynamic data Four pivotal efficacy studies, one of which was a dose-finding study Three pivotal safety studies Six other efficacy/safety studies Integrated analysis set (LVHG, LVHJ, LVHR, LVID) literature references Comment: Four pivotal efficacy studies relate to the proposed indication of the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men, namely studies LVHG, LVHJ, LVHR and LVID. Study LVHR also relates to the proposed indication of treatment of ED and the signs and symptoms of BPH (ED/BPH) in adult men. One of the ten clinical pharmacology studies (LVHN) evaluated the pharmacokinetics and cardiovascular dynamics of tadalafil in young and elderly men with BPH-LUTS. One safety and efficacy study (LVDI) relates to the use of tadalafil in men with ED only. A number of the non- clinical efficacy and safety studies and clinical pharmacology studies were in Asian study populations. The clinical dossier includes reports of bioanalytical and analytical methods for human studies and other non-clinical information relating to method validation and sample testing. Paediatric data The submission did not include paediatric data. Good clinical practice The sponsor states that their sponsored studies were conducted following standard research design conventions in accordance with International Conference on Harmonisation (ICH) guidelines, good clinical practice procedures and local regulatory requirements. The sponsor also indicates that clinical studies were conducted in accordance with the spirit of the Declaration of Helsinki and were conducted in compliance with on Good Clinical “Ordinance Practice” and of Good Clinical Practice”. “Details Pharmacokinetics Studies providing pharmacokinetic data Only one pharmacokinetic study was submitted to specifically support the proposed BPH indication (Study LVHN). Other conventional pharmacokinetic studies were submitted in this application as they were included in the integrated clinical pharmacology analysis set.
Contents of the clinical dossier of the clinical dossier The clinical dossier documented a development program of pharmacology, efficacy and safety studies relating to the proposed extension of indications. The submission contained the following clinical information: Ten clinical pharmacology studies, including six that provided pharmacokinetic data and six that provided pharmacodynamic data Four pivotal efficacy studies, one of which was a dose-finding study Three pivotal safety studies Six other efficacy/safety studies Integrated analysis set (LVHG, LVHJ, LVHR, LVID) literature references Comment: Four pivotal efficacy studies relate to the proposed indication of the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH) in adult men, namely studies LVHG, LVHJ, LVHR and LVID. Study LVHR also relates to the proposed indication of treatment of ED and the signs and symptoms of BPH (ED/BPH) in adult men. One of the ten clinical pharmacology studies (LVHN) evaluated the pharmacokinetics and cardiovascular dynamics of tadalafil in young and elderly men with BPH-LUTS. One safety and efficacy study (LVDI) relates to the use of tadalafil in men with ED only. A number of the clinical efficacy and safety studies and clinical pharmacology studies were in Asian study populations. The clinical dossier includes reports of bioanalytical and analytical methods for human studies and other non-clinical information relating to method validation and sample testing. Paediatric data The submission did not include paediatric data. Good clinical practice The sponsor states that their sponsored studies were conducted following standard research design conventions in accordance with International Conference on Harmonisation (ICH) guidelines, good clinical practice procedures and local regulatory requirements. The sponsor also indicates that clinical studies were conducted in accordance with the spirit of the Declaration of Helsinki and were conducted in compliance with “Ordinance on Good Clinical Practice” and “Details of Good Clinical Practice”. Pharmacokinetics Studies providing pharmacokinetic data Only one pharmacokinetic study was submitted to specifically support the proposed BPH indication (Study LVHN). Other conventional pharmacokinetic studies were submitted in this application as they were included in the integrated clinical pharmacology analysis set. non-