Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
This study has been terminated.
(The requirement for Post Marketing Surveillance was lifted by the Philippine FDA)
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200407
First received: August 25, 2010
Last updated: March 17, 2016
Last verified: March 2016
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Purpose
The purpose of this study is to determine the safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Hypertensive Filipino patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypertension |
Drug: Amlodipine + Olmesartan medoxomil |
Phase 4 |
| Study Type: | Observational |
| Study Design: | 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 |
Resource links provided by NLM:
Further study details as provided by Pfizer:
Primary Outcome Measures:
- Number of participants with each Adverse Events being reported [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Efficacy: change from baseline in mean SBP and DBP at week 12 using the LOCF [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
- Efficacy: change from baseline in mean SBP and DBP at week 4, 8 and 12 without LOCF [ Time Frame: 4, 8 and 12 weeks ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: Yes ]
| Enrollment: | 615 |
| Study Start Date: | June 2010 |
| Study Completion Date: | January 2014 |
| Primary Completion Date: | January 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200407
Hide Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200407
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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 |
More Information
Additional Information:
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01200407 History of Changes |
| Other Study ID Numbers: | B1581001 |
| Study First Received: | August 25, 2010 |
| Last Updated: | March 17, 2016 |
| Health Authority: | Philippines: Ethics Committee |
Keywords provided by Pfizer:
|
Hypertension fixed drug combination Filipinos Amlodipine |
Olmesartan medoxomil uncontrolled hypertension difficult to treat hypertension |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on September 30, 2016