A randomized, double-blind, double-dummy, parallel group, active controlled multi-center clinical trial to evaluate the additional efficacy and safety of Olmesartan Medoxomil/Amlodipine 20/5 mg in Chinese patients with mild or moderate essential hypertension who failed to achieve their goal with Olmesartan Medoxomil 20mg monotherapy

Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.0 个研究点目标入组 252 人开始时间: 待定

试验速览

阶段: 3 期
发起方: Daiichi Sankyo Pharmaceutical (Shanghai) Co., Ltd.
入组人数: 252
主要终点: Compare the mean change in trough SeDBP from baseline to Visit 6 between two groups

暂无简介。

研究类型: Interventional
干预模型: This study was designed as a randomized, double-blind, double-dummy, active-controlled, parallel group, multi-center clinical trial.

•Outpatients with mild or moderate essential hypertension if they satisfy the following main inclusion criteria:
•Male or female, age of 18-75 years (inclusive);
•At visit 3, Mean SeDBP >= 95 mmHg and <110 mmHg;
•At visit 4, Mean SeDBP >= 90 mmHg;
•No significant abnormality in hematology, kidney, liver, cardiovascular or endocrinology system;
•Subject was willing and able to take study medications as prescribed and complied with other study requirements;
•Subject was able to give his/her written informed consent to participate in this study.
•During the whole study, the subject will be removed from the study immediately and given appropriate treatment if his/her mean SeDBP>=110 mmHg and/or mean SeSBP>=180 mmHg.

Compare the mean change in trough SeDBP from baseline to Visit 6 between two groups

时间窗: Visit 6

BP values measured at Visit 4 is taken as baseline value

Compare the mean change in trough SeSBP from Visit 4 to Visit 6 between two groups(Visit 4 to Visit 6)
Compare the mean change in trough SeDBP and trough SeSBP from Visit 4 to Visit 5 between two groups(Visit 4 to Visit 5)
Evaluate the percentage of responders in the two groups at Visit 5 and Visit 6(Visit 5 and Visit 6)

发起方