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Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

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NCT01200407

Last updated on November 8, 2019
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FOR MORE INFORMATION
Study Location
Lorma Medical Center
San Fernando City, La Union, 2500 Philippines
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
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
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

NCT01200407
Pfizer
Terminated
Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

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Descriptive Information
Brief TitleAmlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
Official TitleAn 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 SummaryThe purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.
Detailed DescriptionNot Provided
Study TypeObservational
Study DesignTime Perspective: Prospective
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationFilipino Hypertensive patients ages 18-65 years old
ConditionHypertension
InterventionDrug: 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/CohortsFilipino 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 StatusTerminated
Actual Enrollment
 (submitted: March 17, 2016)		615
Original Estimated Enrollment
 (submitted: September 10, 2010)		3000
Actual Study Completion DateJanuary 2014
Actual Primary Completion DateJanuary 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study:All
Ages18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy VolunteersNo
ContactsContact information is only displayed when the study is recruiting subjects
Listed Location CountriesPhilippines
Removed Location Countries  
 
Administrative Information
NCT NumberNCT01200407
Other Study ID NumbersB1581001
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyPfizer
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateMarch 2016

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

BY EMAIL

Contact

[email protected]

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