NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JAPIC ID: JapicCTI-111581

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 : Amlodipine INN of the control intervention : amlodipine Dosage And administration of the control intervention : Amlodipine 5mg 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 OutcomeEfficacy 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.

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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