Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide
NCT00796159
ABOUT THIS STUDY
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- 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)
- Pregnant of Lactating women
- History of secondary hypertension
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Descriptive Information | ||||
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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 | 1723 | |||
Original Estimated Enrollment | 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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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PRS Account | Pfizer | |||
Verification Date | December 2009 |