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
Phase 3
- Conditions
- Essential Hypertension
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 252
Inclusion Criteria
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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy parameters<br>Primary efficacy parameter<br>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)<br>Safety parameters<br>Incidence of adverse events, clinically relevant laboratory abnormalities, abnormal physical examination findings and ECG findings experienced before and after treatment.
- Secondary Outcome Measures
Name Time Method Efficacy parameters<br>Secondary efficacy parameters<br>-Compare the mean change in trough SeSBP from Visit 4 to Visit 6 between two groups;<br>-Compare the mean change in trough SeDBP and trough SeSBP from Visit 4 to Visit 5 between two groups;<br>-Evaluate the percentage of responders in the two groups at Visit 5 and Visit 6.<br>Responder is defined as:<br>-whose BP decreases to SeDBP<90 mmHg and SeSBP<140 mmHg, or<br>-whose mean decrease of trough SeDBP is>10 mmHg cumulatively from Visit 4 to the time of evaluation, or<br>-whose mean decrease of trough SeSBP is>20 mmHg cumulatively from Visit 4 to the time of evaluation.