Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01200407 |
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Recruitment Status
:
Terminated
(The requirement for Post Marketing Surveillance was lifted by the Philippine FDA)
First Posted
: September 13, 2010
Last Update Posted
: March 21, 2016
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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Brief Summary:
The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.
| Condition or disease | Intervention/treatment |
|---|---|
| Hypertension | Drug: Amlodipine + Olmesartan medoxomil |
| Study Type : | Observational |
| Actual Enrollment : | 615 participants |
| Time Perspective: | Prospective |
| Official Title: | An Open Label, Non-interventional Study Of The Safety, Tolerability, And Efficacy Of Amlodipine And Olmesartan Medoxomil (Normetec) In Filipino Patients With Hypertension: A Post Marketing Surveillance Study |
| Study Start Date : | June 2010 |
| Actual Primary Completion Date : | January 2014 |
| Actual Study Completion Date : | January 2014 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Filipino Hypertensive patients
Male and Female, 18 to 65 year old Filipino hypertensive patients prescribed by their doctors with Normetec
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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
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Primary Outcome Measures
:
- Number of participants with each Adverse Events being reported [ Time Frame: 4 weeks ]
Secondary Outcome Measures
:
- Efficacy: change from baseline in mean SBP and DBP at week 12 using the LOCF [ Time Frame: 12 weeks ]
- Efficacy: change from baseline in mean SBP and DBP at week 4, 8 and 12 without LOCF [ Time Frame: 4, 8 and 12 weeks ]
- Efficacy: proportion of subjects achieving the JNC VII recommended BP goal (<140/90 mmHg; <130/80 mmHg for subjects with diabetes) at week 12 with LOCF [ Time Frame: 12 weeks ]
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Filipino Hypertensive patients ages 18-65 years old
Criteria
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01200407
Hide Study Locations
Locations
| Philippines | |
| Lorma Medical Center | |
| San Fernando City, La Union, Philippines, 2500 | |
| Holy Child Hospital | |
| Taclobo, Dumaguete City, Negros Oriental, Philippines | |
| Private Clinic | |
| Albay, Philippines | |
| Private Clinic | |
| Angono, Philippines | |
| Private Clinic | |
| Baguio City, Philippines | |
| Pines City Doctors Hospital | |
| Baguio, Philippines | |
| Private Clinic | |
| Bulacan, Philippines | |
| Private Clinic | |
| Calamba, Philippines | |
| Private Clinic | |
| Cavite, Philippines | |
| Private Clinic | |
| Cebu City, Philippines | |
| Private Clinic | |
| Cebu, Philippines | |
| Private Clinic | |
| Dagupan, Philippines | |
| Private Clinic | |
| Davao City, Philippines | |
| Private Clinic | |
| Davao, Philippines | |
| Private Clinic | |
| Eastwood, Philippines | |
| Private Clinic | |
| Iloilo City, Philippines | |
| Private Clinic | |
| Iloilo, 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 | |
| Makati Medical Center | |
| Makati City, Philippines | |
| Private Clinic | |
| Makati City, Philippines | |
| Private Clinic | |
| Makati, 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 | |
| Marikina, 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 City, Philippines | |
| Dr. Agnes Vargas | |
| Pasig Ciy, Philippines | |
| Private cCinic | |
| Pasig, Philippines | |
| Private Clinic | |
| Pasig, Philippines | |
| Private Clinic | |
| Puerto Princesa, Philippines | |
| Armed Forces of the Philippines Medical Center | |
| Quezon City, Philippines | |
| Private Clinic | |
| Quezon CIty, Philippines | |
| Angono Medics | |
| Rizal, Philippines | |
| Private Clinic | |
| San Juan, Philippines | |
| Private Clinic | |
| Tacloban, Philippines | |
| Private Clinic | |
| Taguig, Philippines | |
| Private Clinic | |
| Tarlac, Philippines | |
| Private Clinic | |
| Tugegarao, Philippines | |
| Priavte Clinic | |
| Tuguegarao City, Philippines | |
| Private Clinic | |
| Tuguegarao City, Philippines | |
Sponsors and Collaborators
Pfizer
Investigators
| Study Director: | Pfizer CT.gov Call Center | Pfizer |
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01200407 History of Changes |
| Other Study ID Numbers: |
B1581001 |
| First Posted: | September 13, 2010 Key Record Dates |
| Last Update Posted: | March 21, 2016 |
| Last Verified: | March 2016 |
Keywords provided by Pfizer:
|
Hypertension fixed drug combination Filipinos Amlodipine |
Olmesartan medoxomil uncontrolled hypertension difficult to treat hypertension |
Additional relevant MeSH terms:
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Hypertension Vascular Diseases Cardiovascular Diseases Olmesartan Amlodipine Olmesartan Medoxomil Amlodipine Besylate, Olmesartan Medoxomil Drug Combination |
Antihypertensive Agents Calcium Channel Blockers Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Vasodilator Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |