Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
NCT01200407
ABOUT THIS STUDY
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- 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
- Patients with contraindications to any of the component of the fixed drug (amlodipine
or olmesartan medoxomil) or with malignant or secondary hypertension
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Descriptive Information | ||||
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Brief Title | Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients | |||
Official Title | 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 | |||
Brief Summary | The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients. | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Filipino Hypertensive patients ages 18-65 years old | |||
Condition | Hypertension | |||
Intervention | Drug: Amlodipine + Olmesartan medoxomil
start dose is 5/20 mg, which can then be uptitrated to 5/40 mg up to 10/40 mg if BP goal is not reached during the 4 week follow-up | |||
Study Groups/Cohorts | Filipino Hypertensive patients
Male and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec Intervention: Drug: Amlodipine + Olmesartan medoxomil | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment | 615 | |||
Original Estimated Enrollment | 3000 | |||
Actual Study Completion Date | January 2014 | |||
Actual Primary Completion Date | January 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| |||
Sex/Gender |
| |||
Ages | 18 Years to 65 Years (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Philippines | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01200407 | |||
Other Study ID Numbers | B1581001 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Pfizer | |||
Study Sponsor | Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
| |||
PRS Account | Pfizer | |||
Verification Date | March 2016 |