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 Amlodipine 5mg monotherapy
This study was designed as a randomized, double-blind, double-dummy, active-controlled, parallel group, multi-center clinical trial.
3
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.
18age old over
75age old under
Both
Essential Hypertension
investigational material(s)
Generic name etc : Olmesartan Medoxomil/Amlodipine
INN of investigational material : olmesartan medoxomil/amlodipine
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : Olmesartan Medoxomil/Amlodipine 20/5mg tablet, PO QD for 8 weeks.
control material(s)
Generic name etc : Amlodipine
INN of investigational material : amlodipine
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : Amlodipine 5mg tablet, PO QD for 8 weeks.
Efficacy parameters
Primary efficacy parameter
Compare the mean change in trough SeDBP from baseline to Visit 6 between two groups (BP values measured at Visit 4 is taken as baseline value)
Safety parameters
Incidence of adverse events, clinically relevant laboratory abnormalities, abnormal physical examination findings and ECG findings experienced before and after treatment.
Efficacy parameters
Secondary efficacy parameters
-Compare the mean change in trough SeSBP from Visit 4 to Visit 6 between two groups;
-Compare the mean change in trough SeDBP and trough SeSBP from Visit 4 to Visit 5 between two groups;
-Evaluate the percentage of responders in the two groups at Visit 5 and Visit 6.
Responder is defined as:
-whose BP decreases to SeDBP<90 mmHg and SeSBP<140 mmHg, or
-whose mean decrease of trough SeDBP is>10 mmHg cumulatively from Visit 4 to the time of evaluation, or
-whose mean decrease of trough SeSBP is>20 mmHg cumulatively from Visit 4 to the time of evaluation.
