NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-111583

Registered date:

Basic Information

Recruitment status
Health condition(s) or Problem(s) studiedEssential Hypertension
Date of first enrollment01/12/2009
Target sample size252
Countries of recruitment
Study typeINTERVENTIONAL
Intervention(s)Intervention name : Olmesartan Medoxomil/Amlodipine INN of the intervention : olmesartan medoxomil/amlodipine Dosage And administration of the intervention : Olmesartan Medoxomil/Amlodipine 20/5mg tablet, PO QD for 8 weeks. Control intervention name : Olmesartan Medoxomil INN of the control intervention : olmesartan medoxomil Dosage And administration of the control intervention : Olmesartan Medoxomil 40mg tablet, PO QD for 8 weeks.

Outcome(s)

Primary OutcomeEfficacy 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 OutcomeSecondary 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.

Key inclusion & exclusion criteria

Age minimum18
Age maximum75
GenderBOTH
Include criteriaOutpatients 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.
Exclude criteria

Related Information

Contact

public contact
Name DAIICHI SANKYO Co.,Ltd. Contact for Clinical Trial Information
Address http://www.daiichisankyo.co.jp/contact/clinical/index.html
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scientific contact
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