HypertensionNCT01200407

Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

An observational study of Hypertension, run by Pfizer at 51 sites in Philippines.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

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

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypertension
What is being tested?: Amlodipine + Olmesartan medoxomil
How many people: 615 participants
Where: 51 sitesPhilippines
Study dates: 9 Jun 2010to 4 Jan 2014
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Study population: Filipino Hypertensive patients ages 18-65 years old

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

51 sites in 1 country.

City, postcode or hospital

51 sites in 1 country

Philippines51 sites

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

Other trials in Philippines

About this study

Official title: 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.

Conditions: Hypertension
Being tested: Amlodipine + Olmesartan medoxomil
Keywords: Hypertension, fixed drug combination, Filipinos, Amlodipine, Olmesartan medoxomil, uncontrolled hypertension, difficult to treat hypertension
Medical subject headings: Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Amlodipine + Olmesartan medoxomilDrug
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

Study groups in NCT01200407
Study group	Role	What they receive
Filipino Hypertensive patients		Male and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec Receives: Drug: Amlodipine + Olmesartan medoxomil

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
Measured: Baseline, Week 12

Secondary outcomes (2)

Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF
Measured: Baseline, Week 4, Week 8, Week 12
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.
Measured: Baseline, Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

9 Jun 20104 Jan 2014

First posted13 Sep 2010 (estimated)
Study start9 Jun 2010
Primary completion4 Jan 2014
Study completion4 Jan 2014

Why it stopped: The requirement for Post Marketing Surveillance was lifted by the Philippine FDA

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by PfizerThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Other
Time perspective: Prospective
Enrolment: 615 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01200407
Sponsor's protocol ID: B1581001
Status last verified: Jul 2021
First submitted: 25 Aug 2010
Last updated: 17 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT01200407
Acronym / sponsor ID: B1581001
Conditions: Hypertension
Keywords: Hypertension, fixed drug combination, Filipinos, Amlodipine, Olmesartan medoxomil, uncontrolled hypertension, difficult to treat hypertension
Study type: Observational
Recruitment status: TerminatedReason stopped: The requirement for Post Marketing Surveillance was lifted by the Philippine FDA
Enrolment: 615 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: 9 Jun 2010 (actual)
Primary completion: 4 Jan 2014 (actual)
Study completion: 4 Jan 2014 (actual)
First posted: 13 Sep 2010 (estimated)
Results: Posted 17 Aug 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Other
Time perspective: Prospective
Number of arms: 1

Arm	Type	Receives
Filipino Hypertensive patients	–	Drug: Amlodipine + Olmesartan medoxomilMale and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: Filipino Hypertensive patients ages 18-65 years old

Key inclusion criteria (1 listed)

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

Key exclusion criteria (1 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Amlodipine + Olmesartan medoxomilstart 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	Drug	Filipino Hypertensive patients

Primary outcome

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.
Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)
Time frame: Baseline, Week 12

2 secondary outcomes

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
Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF
Time frame: Baseline, Week 12

Results and safety

Results posted to the registry on 17 Aug 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normetec	615	533

Primary outcome: 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). Number. Unit: participants

Measure	Normetec n = 613
Number of Participants with AEs	6
Number of Participants with SAEs	0

Population analysed: The safety analysis population included all participants who received at least 1 dose of study medication during the observation period.

Primary outcome: Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)

Time frame: Baseline, Week 12. Mean (Standard Deviation). Unit: millimeters of mercury (mmHg)

Measure	Normetec n = 613
Baseline: SBP	161.6 (16.04)
Baseline: DBP	98.9 (9.33)
Change at Week 12: SBP LOCF	-35.8 (16.74)
Change at Week12: DBP LOCF	-19.4 (10.39)

Normetec: Mean Difference (Net): -35.8 (95% CI -37.2 to -34.4), p = 0.000, t-test, 2 sided
Normetec: Mean Difference (Net): -19.4 (95% CI -20.3 to -18.6), p = 0.000, t-test, 2 sided

Population analysed: 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.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to 28 days after last study drug administration (Week 12). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normetec	0 of 613 (0%)	6 of 613 (1%)	Not reported

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No. 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.

Related trials for Hypertension

Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

51 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Hypertension, run by Pfizer at 51 sites in Philippines.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 sites in Philippines. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 17 Aug 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01200407.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.