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
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 : Olmesartan Medoxomil
INN of investigational material : olmesartan medoxomil
Therapeutic category code : 214 Antihypertensives
Dosage and Administration for Investigational material : Olmesartan Medoxomil 40mg 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.
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.
