Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide
NCT00796159
Last updated date
ABOUT THIS STUDY
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
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
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
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 | 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 | |||