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The requirement for Post Marketing Surveillance was lifted by the Philippine FDA
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The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Filipino Hypertensive patients | Male and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amlodipine + Olmesartan medoxomil | Drug | start dose is 5/20 mg, which can then be uptitrated to 5/40 mg up to 10/40 mg if BP goal is not reached during the 4 week follow-up |
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| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | Baseline up to 28 days after last study drug administration (Week 12) |
| Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | Baseline, Week 4, Week 8, Week 12 | |
| Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF |
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Inclusion Criteria:
Exclusion Criteria:
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Filipino Hypertensive patients ages 18-65 years old
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lorma Medical Center | San Fernando City | LA Union | 2500 | Philippines | ||
| Holy Child Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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The diagnostic criteria of hypertension (defined by Joint National Committee on Prevention, Detection, Evaluation, and Treatment of High Blood Pressure [JNC VII] as systolic blood pressure [BP] >=140 mmHg and diastolic BP >=90 mmHg) and the dosage of study medication were consistent with the investigator's routine clinical setting.
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| ID | Title | Description |
|---|---|---|
| FG000 | Normetec | Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Based on JNC VII, the ultimate public health goal of antihypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. The JNC VII recommended BP goal is <140/90 mmHg and <130/80 mmHg for participants with diabetes.
| Baseline, Week 12 |
| Taclobo, Dumaguete City |
| Negros Oriental |
| Philippines |
| Private Clinic | Albay | Philippines |
| Private Clinic | Angono | Philippines |
| Pines City Doctors Hospital | Baguio City | Philippines |
| Private Clinic | Baguio City | Philippines |
| Private Clinic | Bulacan | Philippines |
| Private Clinic | Calamba | Philippines |
| Private Clinic | Cavite | Philippines |
| Private Clinic | Cebu | Philippines |
| Private Clinic | Cebu City | Philippines |
| Private Clinic | City of Muntinlupa | Philippines |
| Private Clinic | City of Taguig | Philippines |
| Private Clinic | Dagupan | Philippines |
| Private Clinic | Davao City | Philippines |
| Private Clinic | Eastwood | Philippines |
| Private Clinic | Iloilo City | Philippines |
| Private Clinic | Isabela | Philippines |
| Private Clinic | Kalibo Aklan | Philippines |
| Private Clinic | Laguna | Philippines |
| Private Clinic | Laoag | Philippines |
| Jesus Nazarene General Hospital | Lingayen, Pangasinan | Philippines |
| Private Clinic | Makati | Philippines |
| Makati Medical Center | Makati City | Philippines |
| Private Clinic | Makati City | Philippines |
| Private Clinic | Mandaluyong | Philippines |
| Healthway Medical Clinic | Manila | Philippines |
| Isaac and Catalina Medical Center | Manila | Philippines |
| Metropolitan Medical Center Institutional Review Board | Manila | Philippines |
| Metropolitan Medical Center | Manila | Philippines |
| Private Clinic | Manila | Philippines |
| The Medical City | Manila | Philippines |
| Private Clinic | Marikina City | Philippines |
| Private Clinic | Metro Manila | Philippines |
| Private Clinic | Nueva Vizcaya | Philippines |
| Private Clinic | Olongapo City | Philippines |
| Private Clinic | Pampanga | Philippines |
| Private Clinic | Paranaque City | Philippines |
| Private Clinic | Pasay | Philippines |
| Private cCinic | Pasig | Philippines |
| Private Clinic | Pasig | Philippines |
| Dr. Agnes Vargas | Pasig Ciy | Philippines |
| Private Clinic | Puerto Princesa City | Philippines |
| Armed Forces of the Philippines Medical Center | Quezon City | Philippines |
| Private Clinic | Quezon City | Philippines |
| Angono Medics | Rizal | Philippines |
| Private Clinic | San Juan City | Philippines |
| Private Clinic | Tacloban City | Philippines |
| Private Clinic | Tarlac City | Philippines |
| Priavte Clinic | Tuguegarao City | Philippines |
| Private Clinic | Tuguegarao City | Philippines |
| COMPLETED |
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| NOT COMPLETED |
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The full analysis set included all subjects who received at atleast 1 dose of amlodipine and olmesartan medoxomil.
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| ID | Title | Description |
|---|---|---|
| BG000 | Normetec | Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex/Gender, Customized | Count of Participants | Participants |
| ||||||||||||||||||
| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs) | An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs. | The safety analysis population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Number | participants | Baseline up to 28 days after last study drug administration (Week 12) |
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| Primary | Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF) | The full analysis population included all participants who received at least 1 dose of study medication during the observation period; number analyzed=number of participants with observed value in category. LOCF method was used to impute missing values. | Posted | Mean | Standard Deviation | millimeters of mercury (mmHg) | Baseline, Week 12 |
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| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF | The full analysis population included all participants who received at least 1 dose of study medication during the observation period; number analyzed=number of participants with observed value in category. | Posted | Mean | Standard Deviation | mmHg | Baseline, Week 4, Week 8, Week 12 |
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| Secondary | Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF | Based on JNC VII, the ultimate public health goal of antihypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. The JNC VII recommended BP goal is <140/90 mmHg and <130/80 mmHg for participants with diabetes. | The full analysis population included all participants who received at least 1 dose of study medication during the observation period. | Posted | Number | 95% Confidence Interval | percentage of participants | Baseline, Week 12 |
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Baseline up to 28 days after last study drug administration (Week 12)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Normetec | Amlodipine/olmesartan medoxomil(Normetec) was prescribed and administered at the recommended starting dose of 5/20 milligrams (mg) once daily according to approved product information in the Philippines. | 0 | 613 | 6 | 613 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Chest Pain | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Oedema peripheral | General disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Drug hypersensitivity | Immune system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Migraine | Nervous system disorders | MedDRA 18.1 | Non-systematic Assessment |
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| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 18.1 | Non-systematic Assessment |
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This was an observational, non-interventional study which evaluated Filipino patients with hypertension at the outpatient clinic, and as such, study medication was prescribed at the discretion of the attending physician.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single enter publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D017311 | Amlodipine |
| D000068557 | Olmesartan Medoxomil |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D007093 | Imidazoles |
| D001393 | Azoles |
| D013777 | Tetrazoles |
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| Unspecified |
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