Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

NCT00796159

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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 <=179 mmHg OR DBP of >=90 and <=109 mmHg)

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

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Advanced Information
Descriptive Information
Brief Title Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide
Official Title A 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 Summary This 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 Description Non Probability Sampling
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Filipino patients with Uncontrolled Mild to Moderate Essential Hypertension
Condition Hypertension
Intervention Drug: Olmesartan medoxomil
olmesartan medoxomil 20 mg and HCTZ 12.5 mg
Study Groups/Cohorts Olmesartan 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 Status Completed
Actual Enrollment
 (submitted: July 13, 2009)
1723
Original Estimated Enrollment
 (submitted: November 21, 2008)
3000
Actual Study Completion Date December 2008
Actual Primary Completion Date December 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
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 Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT00796159
Other Study ID Numbers A0021004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date December 2009