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Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

Last updated on October 12, 2019

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Study Location
Contact
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
18-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male and Female patients 18 to 65 y/old

- Patient previously taking low-dose medoxomil or any other ARB alone with uncontrolled
BP

- Patient with uncontrolled mild to moderate hypertension (SBP>= 140 and DBP of >=90 and

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Pregnant of Lactating women

- History of secondary hypertension

NCT00796159
Pfizer
Completed
Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

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Descriptive Information
Brief TitlePost-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide
Official TitleA Post Marketing Surveillance, Multicenter, Open-Label, Dose-Titrating, 4-Week Study Evaluating The Efficacy, Tolerability And Safety Of Olmesartan Medoxomil 20mg In Combination With 12.5mg Hydrochlorothiazide In Subjects With Stage 1 To Stage 2 Hypertension
Brief SummaryThis is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects with mild to moderate essential hypertension
Detailed DescriptionNon Probability Sampling
Study TypeObservational
Study DesignObservational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up DurationNot Provided
BiospecimenNot Provided
Sampling MethodNon-Probability Sample
Study PopulationFilipino patients with Uncontrolled Mild to Moderate Essential Hypertension
ConditionHypertension
InterventionDrug: Olmesartan medoxomil
olmesartan medoxomil 20 mg and HCTZ 12.5 mg
Study Groups/CohortsOlmesartan medoxomil + HCTZ
Intervention: Drug: 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 StatusCompleted
Actual Enrollment
 (submitted: July 13, 2009)
1723
Original Estimated Enrollment
 (submitted: November 21, 2008)
3000
Actual Study Completion DateDecember 2008
Actual Primary Completion DateDecember 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Male and Female patients 18 to 65 y/old
  • Patient previously taking low-dose medoxomil or any other ARB alone with uncontrolled BP
  • Patient with uncontrolled mild to moderate hypertension (SBP>= 140 and <=179 mmHg OR DBP of >=90 and <=109 mmHg)

Exclusion Criteria:

  • Pregnant of Lactating women
  • History of 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 CountriesNot Provided
Removed Location Countries  
 
Administrative Information
NCT NumberNCT00796159
Other Study ID NumbersA0021004
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing StatementNot Provided
Responsible PartyDirector, Clinical Trial Disclosure Group, Pfizer, Inc.
Study SponsorPfizer
CollaboratorsNot Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateDecember 2009

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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