Subjects with serious disorders which may limit the ability to evaluate the efficacy or safety of the investigational products, including cerebrovascular, cardiovascular, renal, respiratory, hepatic, gastrointestinal, endocrine or metabolic, haematologic or, neurologic, and psychiatric diseases. Exclusion Criteria: - Female subjects of childbearing potential who are pregnant or lactating.
Azor 10 40mg Patch#
Adequate contraceptives include hormonal intra-uterine devices, hormonal contraceptives (oral, depot, patch or injectable), and double barrier methods such as condoms or diaphragms with spermicidal gel or foam. Female subjects of childbearing potential must be using adequate contraception (female of childbearing potential is defined as one who has not been postmenopausal for at least one year, or has not been surgically sterilised, or has not had a hysterectomy at least three months prior to the start of this study ). Subjects freely sign the informed consent form (ICF) after the nature of the study and the disclosure of his/her data has been explained. All subjects undergoing washout of their prior antihypertensive medication will have the opportunity to re-visit the study sites for additional visits during washout (Visits 2 and 2.1) to assess eligibility for randomisation. Subjects washing out of HTN medication must meet this requirement at least by Visit 2 (or Visit 2.1, if needed) and Visit 3. Subjects not currently on antihypertensive (HTN) medication may meet this requirement at the screening visit (Visit 1) and the randomization visit (Visit 3). The difference in mean SeSBP/SeDBP between the visit prior to randomisation and the randomisation visit must be ≤ 20/10 mmHg. Subjects with mean trough seated blood pressure (SeBP) ≥ 160/100 mmHg, (seated systolic blood pressure(SeSBP) ≥ 160 mmHg and seated diastolic blood pressure (SeDBP) ≥ 100 mmHg) at Screening if not currently on antihypertensive medication (newly diagnosed subjects or subjects who are not taking any antihypertensive medication for at least 3 weeks) Or Subjects with mean trough SeBP ≥ 160/100 mmHg, SeSBP ≥ 160 mmHg and SeDBP ≥ 100 mmHg) after washout of prior antihypertensive medication in subjects who discontinued their previous antihypertensive medication. Inclusion Criteria: - Male or female subjects aged 18 years or older. One olmesartan medoxomil 40 mg + amlodipine 10 mg combination oral tablet taken once per day. One olmesartan medoxomil 40 mg + amlodipine 5 mg combination oral tablet taken once per day. One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day Olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/25mg Two hydrochlorothiazide 12.5 mg tablets taken once per day. Olmesartan/amlodipine/hydrochlorothiazide 40mg/10mg/12.5mg One hydrochlorothiazide 12.5 mg tablet + one hydrochlorothiazide 12.5 mg placebo tablet taken once per day. Olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/25mg Olmesartan medoxomil + amlodipine + hydroclororthiazide Olmesartan/amlodipine/hydrochlorothiazide 40mg/5mg/12.5mg
Olmesartan medoxomil + amlodipine + hydrochlorothiazide + placebo
Olmesartan/amlodipine/hydrochlorothiazide 20mg/5mg/12.5mg
One olmesartan medoxomil 20 mg + amlodipine 5 mg combination oral tablet taken once per day. Olmesartan medoxomil + amlodipine + hydroclororthiazide + placebo Number of Subjects Reaching Blood Pressure Goal at Week 26Ĭhange in Seated Systolic Blood Pressure (SeDBP) During Open-Label Period VI (Titration Effect From OM/AML/HCTZ 40/5/25 to 40/10/25. Number of Subjects Reaching Blood Pressure Goal From Week 18 to Week 22Ĭhange in Seated Diastolic Blood Pressure From Week 22 to Week 26Ĭhange in Seated Systolic Blood Pressure From Week 22 to Week 26 Number of Subjects Reaching Blood Pressure Goal at Week 10Ĭhange in Seated Diastolic Blood Pressure From Week 18 to Week 22Ĭhange in Seated Systolic Blood Pressure From Week 18 to Week 22 Change in Seated Diastolic Blood Pressure (SeDBP).Ĭhange in Seated Systolic Blood Pressure (SeDBP).
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