Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
NCT01200407
Last updated date
ABOUT THIS STUDY
The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine
and Olmesartan medoxomil among Hypertensive Filipino patients.
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
By phone
Pfizer Clinical Trials Contact Center
1-800-718-1021
Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hypertension
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details
- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details
- 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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Advanced Information
| Descriptive Information | ||||
|---|---|---|---|---|
| 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 | |||