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

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221541

Enrollment

252

Registered

2011-08-11

Start date

2011-08-11

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Essential Hypertension

Interventions

investigational material(s) Generic name etc : Olmesartan Medoxomil/Amlodipine INN of investigational material : olmesartan medoxomil/amlodipine Therapeutic category code : 214 Antihypertensives Dosag

Eligibility

Sex/Gender

All

Inclusion criteria

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 = 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

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 SeDBP10 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.	—

Measure

Time frame

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 SeDBP10 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.

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Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026