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

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

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

Ages Eligible for Study

16 years to 63 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
Intervention / Treatment
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

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

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

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)

June 9, 2010

Primary Completion (Actual)

January 4, 2014

Study Completion (Actual)

January 4, 2014

Study Registration Dates

First Submitted

August 25, 2010

First Submitted That Met QC Criteria

September 10, 2010

First Posted (Estimate)

September 13, 2010

Study Record Updates

Last Update Posted (Actual)

August 17, 2021

Last Update Submitted That Met QC Criteria

July 26, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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