Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

July 26, 2021 updated by: Pfizer

AN OPEN LABEL, NON-INTERVENTIONAL STUDY OF THE SAFETY, TOLERABILITY, AND EFFICACY OF AMLODIPINE AND OLMESARTAN MEDOXOMIL (NORMETECTM) IN FILIPINO PATIENTS WITH HYPERTENSION: A POST MARKETING SURVEILLANCE STUDY

The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
615

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Philippines
      • Albay, Philippines
        • Private Clinic
      • Angono, Philippines
        • Private Clinic
      • Baguio, Philippines
        • Pines City Doctors Hospital
      • 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
      • Dagupan, Philippines
        • Private Clinic
      • Davao, Philippines
        • Private Clinic
      • Davao City, Philippines
        • Private Clinic
      • Eastwood, Philippines
        • Private Clinic
      • Iloilo, Philippines
        • Private Clinic
      • Iloilo City, Philippines
        • Private Clinic
      • Isabela, Philippines
        • Private Clinic
      • Kalibo Aklan, Philippines
        • Private Clinic
      • Laguna, Philippines
        • Private Clinic
      • Laoag, Philippines
        • Private Clinic
      • Lingayen, Pangasinan, Philippines
        • Jesus Nazarene General Hospital
      • Makati, Philippines
        • Private Clinic
      • Makati City, Philippines
        • Makati Medical Center
      • Makati City, Philippines
        • Private Clinic
      • Mandaluyong, Philippines
        • Private Clinic
      • Manila, Philippines
        • Metropolitan Medical Center
      • Manila, Philippines
        • Private Clinic
      • Manila, Philippines
        • The Medical City
      • Manila, Philippines
        • Healthway Medical Clinic
      • Manila, Philippines
        • Isaac and Catalina Medical Center
      • Manila, Philippines
        • Metropolitan Medical Center Institutional Review Board
      • Marikina, Philippines
        • Private Clinic
      • Marikina City, Philippines
        • Private Clinic
      • Metro Manila, Philippines
        • Private Clinic
      • Muntinlupa, Philippines
        • Private Clinic
      • Nueva Vizcaya, Philippines
        • Private Clinic
      • Olongapo, Philippines
        • Private Clinic
      • Pampanga, Philippines
        • Private Clinic
      • Paranaque, Philippines
        • Private Clinic
      • Parañaque, Philippines
        • Private Clinic
      • Pasay, Philippines
        • Private Clinic
      • Pasig, Philippines
        • Private cCinic
      • Pasig, Philippines
        • Private Clinic
      • Pasig City, Philippines
        • Private Clinic
      • Pasig Ciy, Philippines
        • Dr. Agnes Vargas
      • Puerto Princesa, Philippines
        • Private Clinic
      • Quezon City, Philippines
        • Armed Forces of the Philippines Medical Center
      • Quezon City, Philippines
        • Private Clinic
      • Rizal, Philippines
        • Angono Medics
      • San Juan, Philippines
        • Private Clinic
      • Tacloban, Philippines
        • Private Clinic
      • Taguig, Philippines
        • Private Clinic
      • Tarlac, Philippines
        • Private Clinic
      • Tugegarao, Philippines
        • Private Clinic
      • Tuguegarao City, Philippines
        • Priavte Clinic
      • Tuguegarao City, Philippines
        • Private Clinic
    • LA Union
      • San Fernando City, LA Union, Philippines, 2500
        • Lorma Medical Center
    • Negros Oriental
      • Taclobo, Dumaguete City, Negros Oriental, Philippines
        • Holy Child Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 61 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Filipino Hypertensive patients ages 18-65 years old

Description

Inclusion Criteria:

  • Filipino hypertensive subjects ages 18-65 years old whether naive or currently taking any other anti-hypertensive or those on monotherapy using CCBs or ARBs whom they want to shift on a fixed dose combination drug

Exclusion Criteria:

  • Patients with contraindications to any of the component of the fixed drug (amlodipine or olmesartan medoxomil) or with malignant or secondary hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Filipino Hypertensive patients
Male and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec
Drug: Amlodipine + Olmesartan medoxomil
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline up to 28 days after last study drug administration (Week 12)
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)
Time Frame: Baseline, Week 12
Baseline, Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
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
Time Frame: Baseline, Week 4, Week 8, Week 12
Baseline, Week 4, Week 8, Week 12
Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF
Time Frame: Baseline, Week 12
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 9, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 4, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 4, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 25, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 10, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 13, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 17, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • B1581001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

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.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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