Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
This study is enrolling participants by invitation only.
Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200407
First received: August 25, 2010
Last updated: February 9, 2015
Last verified: February 2015
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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 (Normetectm) 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 ]
| Estimated Enrollment: | 3000 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | July 2015 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Filipino Hypertensive patients |
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
|
Detailed Description:
To determine safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Filipino hypertensive patients. Non-probability sample
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| 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
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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
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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 | |
| Pines City Doctors Hospital | |
| Baguio, Philippines | |
| Private Clinic | |
| 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 | |
| Jesus Nazarene General Hospital | |
| Lingayen, Pangasinan, Philippines | |
| Private Clinic | |
| Makati, Philippines | |
| Makati Medical Center | |
| Makati City, Philippines | |
| Private Clinic | |
| Makati City, Philippines | |
| Private Clinic | |
| Mandaluyong, Philippines | |
| Isaac and Catalina Medical Center | |
| Manila, Philippines | |
| Private Clinic | |
| Manila, Philippines | |
| Metropolitan Medical Center | |
| Manila, Philippines | |
| Metropolitan Medical Center Institutional Review Board | |
| Manila, Philippines | |
| Healthway Medical Clinic | |
| Manila, Philippines | |
| The Medical City | |
| Manila, Philippines | |
| Private Clinic | |
| 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 cCinic | |
| Pasig, Philippines | |
| Private Clinic | |
| Pasig, Philippines | |
| Private Clinic | |
| Pasig City, Philippines | |
| Dr. Agnes Vargas | |
| Pasig Ciy, Philippines | |
| Private Clinic | |
| Puerto Princesa, Philippines | |
| Private Clinic | |
| Quezon CIty, Philippines | |
| Armed Forces of the Philippines Medical Center | |
| 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:
No publications provided
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT01200407 History of Changes |
| Other Study ID Numbers: | B1581001 |
| Study First Received: | August 25, 2010 |
| Last Updated: | February 9, 2015 |
| 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 Cardiovascular Diseases Vascular Diseases Amlodipine Olmesartan Olmesartan medoxomil Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Antihypertensive Agents Calcium Channel Blockers Cardiovascular Agents Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Uses Vasodilator Agents |
ClinicalTrials.gov processed this record on March 01, 2015