[Translation] A phase III, case series study of reversal of the anticoagulant effect of dabigatran with intravenous idarucizumab (BI 655075) in patients receiving dabigatran who have uncontrolled bleeding or require emergency surgery or procedures

主要目的是证明能够逆转达比加群对经达比加群酯治疗后出现需要紧急干预的不可控制或危及生命的出血的患者以及需进行急诊手术或其他侵入性操作的患者的抗凝作用。次要目的是评价出血减少或停止出血，评价临床疗效，存在依达赛珠单抗的情况下达比加群的安全性和药代动力学。

[Translation]

The primary objective was to demonstrate the ability to reverse the anticoagulant effect of dabigatran in patients who developed uncontrolled or life-threatening bleeding requiring urgent intervention after dabigatran etexilate treatment and who required emergency surgery or other invasive procedures. Secondary objectives were to evaluate the reduction or cessation of bleeding, clinical efficacy, safety and pharmacokinetics of dabigatran in the presence of idarucizumab.

Start Date08 Oct 2018

Sponsor / Collaborator

Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

[+2]

CTR20160575 / CompletedPhase 1

一项在中国健康男性和女性志愿者中研究idarucizumab逆转达比加群抗凝活性的药代动力学和药效动力学的开放性、I 期试验

[Translation] An open-label, phase I trial investigating the pharmacokinetics and pharmacodynamics of idarucizumab in reversing the anticoagulant activity of dabigatran in healthy Chinese male and female volunteers

研究在达比加群稳态时或在达比加群稳态附近给予idarucizumab 的药代动力学和药效动力学

[Translation]

To investigate the pharmacokinetics and pharmacodynamics of idarucizumab administered at or near dabigatran steady-state

Start Date22 May 2017

Sponsor / Collaborator

Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

[+2]

CTR20170133 / CompletedPhase 1

在中国COPD患者中评价单多次经口吸入噻托溴铵+奥达特罗固定剂量复方制剂和奥达特罗的药代动力学和安全性

[Translation] Evaluation of the pharmacokinetics and safety of single or multiple oral inhalations of tiotropium + olodaterol fixed-dose combination and olodaterol in Chinese patients with COPD

本研究的主要目的是在中国COPD患者中评估噻托溴铵+奥达特罗固定剂量复方制剂（5 μg/5 μg）和奥达特罗（5 μg）通过RESPIMAT吸入器单剂量给药后与达到稳态后的药代动力学。

[Translation]

The primary objective of this study was to evaluate the pharmacokinetics of tiotropium + olodaterol fixed-dose combination (5 μg/5 μg) and olodaterol (5 μg) after single-dose administration and after steady-state administration via RESPIMAT inhaler in Chinese patients with COPD.

Start Date01 Mar 2017

Sponsor / Collaborator

Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

[+2]

100 Clinical Results associated with Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

0 Patents (Medical) associated with Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

Literatures (Medical) associated with Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

01 Dec 2014·Translational NeurodegenerationQ1 · MEDICINE

The efficacy and safety of pramipexole ER versus IR in Chinese patients with Parkinson’s disease: a randomized, double-blind, double-dummy, parallel-group study

Q1 · MEDICINE

ArticleOA

Author: Shang, Huifang ; Gordon, Mark Forrest ; Liu, Yiming ; Chen, Shengdi ; Wang, Ying ; Di, Qing ; Sun, Shenggang ; Zhu, Suiqiang ; Lu, Changhong ; Juhel, Nolwenn ; Liu, Chunfeng ; Ren, Yan

OBJECTIVETo evaluate the non-inferiority of pramipexole extended-release (ER) versus immediate-release (IR) in Chinese patients with Parkinson's disease (PD) in a double-blind, randomized, parallel-group study.METHODSSubjects were Chinese patients with idiopathic PD with diagnosis ≥ 2 years prior to trial, age ≥ 30 years old at diagnosis, and Modified Hoehn and Yahr score 2-4 during 'on'-time. Subjects received treatment with pramipexole ER (n=234) or IR (n=239). Non-inferiority was based on the primary endpoint, the change from baseline to end of maintenance (week 18) in the UPDRS (Parts II + III) total score.RESULTSFor the primary endpoint, the adjusted mean changes (standard error) of UPDRS Parts II + III at week 18 were -13.81 (0.655) and -13.05 (0.643) for ER and IR formulations, respectively, using ANCOVA adjusted for treatment and centre (fixed effect) and baseline (covariate). The adjusted mean between group difference was 0.8 for the 2-sided 95% CI (-1.047, 2.566). Since the lower limit of the 2-sided 95% CI (-1.047) for treatment difference was higher than the non-inferiority margin of -4, non-inferiority between pramipexole ER and IR was demonstrated. The incidence of adverse events (AEs) was 68.8% in the ER arm and 73.6% in the IR arm with few severe AEs (ER: 2.1%; IR: 3.8%).CONCLUSIONBased on the UPDRS II + III score, pramipexole ER was non-inferior to pramipexole IR. The safety profiles of pramipexole ER and IR were similar. These results were based on comparable mean daily doses and durations of treatment for both formulations.

01 Feb 2014·Journal of International Medical ResearchQ4 · MEDICINE

A randomized, double-blind study to evaluate the efficacy and safety of a single-pill combination of telmisartan 80 mg/amlodipine 5 mg versus amlodipine 5 mg in hypertensive Asian patients

Q4 · MEDICINE

ArticleOA

Author: Zhu, Dingliang ; Huang, Chenglei ; Gao, Pingjin ; Holtbruegge, Werner

Objective To investigate the efficacy and safety of telmisartan 80 mg/amlodipine 5 mg (T80/A5) single-pill combination versus A5 in patients with essential hypertension not adequately controlled on A5 monotherapy. Methods Asian patients ≥18 years old, with inadequately controlled blood pressure (BP) at enrolment, who failed to achieve a seated diastolic BP (DBP) goal (≥90 mmHg) following 6-weeks’ open-label A5 treatment, were randomly allocated 1 : 1 to 8 weeks’ double-blind treatment with T80/A5 single-pill combination or A5. Results A total of 324 patients entered the double-blind treatment phase. The adjusted mean ± SE reduction in seated trough DBP from baseline to week 8 was significantly greater with T80/A5 (12.4 ± 1.0 mmHg) than A5 (10.2 ± 0.9 mmHg [primary endpoint, n = 314]). Results were similar in the subset of 262 Chinese patients. Treatment-related adverse events were 1.9% with T80/A5 and 2.4% with A5. Conclusions In Asian patients with hypertension, T80/A5 single-pill combination provided improved BP reduction after 8 weeks’ treatment compared with A5 monotherapy. Both treatments were well tolerated.

100 Deals associated with Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

100 Translational Medicine associated with Boehringer Ingelheim International Trading (Shanghai) Co. Ltd.

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