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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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11 April 2016 |
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Main ID: |
NCT01200407 |
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Date of registration:
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25/08/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
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Scientific title:
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An Open Label, Non-interventional Study Of The Safety, Tolerability, And Efficacy Of Amlodipine And Olmesartan Medoxomil (Normetec) In Filipino Patients With Hypertension: A Post Marketing Surveillance Study |
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Date of first enrolment:
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June 2010 |
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Target sample size:
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615 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT01200407 |
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Study type:
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Observational |
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Study design:
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Time Perspective: Prospective
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Phase:
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Countries of recruitment
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Philippines
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Contacts
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Name:
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Pfizer CT.gov Call Center |
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Address:
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Telephone:
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Email:
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Affiliation:
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Pfizer |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Filipino hypertensive subjects ages 18-65 years old whether naive or currently taking
any other anti-hypertensive or those on monotherapy using CCBs or ARBs whom they want
to shift on a fixed dose combination drug
Exclusion Criteria:
- Patients with contraindications to any of the component of the fixed drug (amlodipine
or olmesartan medoxomil) or with malignant or secondary hypertension
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Hypertension
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Intervention(s)
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Drug: Amlodipine + Olmesartan medoxomil
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Primary Outcome(s)
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Number of participants with each Adverse Events being reported
[Time Frame: 4 weeks]
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Secondary Outcome(s)
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Efficacy: change from baseline in mean SBP and DBP at week 12 using the LOCF
[Time Frame: 12 weeks]
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Efficacy: change from baseline in mean SBP and DBP at week 4, 8 and 12 without LOCF
[Time Frame: 4, 8 and 12 weeks]
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Efficacy: proportion of subjects achieving the JNC VII recommended BP goal (<140/90 mmHg; <130/80 mmHg for subjects with diabetes) at week 12 with LOCF
[Time Frame: 12 weeks]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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