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
- 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
- Pregnant of Lactating women
- History of secondary hypertension
Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative
| 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 | 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:
| |||
| 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 | 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 |
| |||
| PRS Account | Pfizer | |||
| Verification Date | December 2009 | |||
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
