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Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

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
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
Information provided by (Responsible Party):

Study Description
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 Phase
Hypertension Drug: Amlodipine + Olmesartan medoxomil Phase 4

Study Design

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
Primary Completion Date : January 2014
Study Completion Date : January 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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

Outcome Measures

Primary Outcome Measures :
  1. Number of participants with each Adverse Events being reported [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Efficacy: change from baseline in mean SBP and DBP at week 12 using the LOCF [ Time Frame: 12 weeks ]
  2. Efficacy: change from baseline in mean SBP and DBP at week 4, 8 and 12 without LOCF [ Time Frame: 4, 8 and 12 weeks ]
  3. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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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

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

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
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
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
First Posted: September 13, 2010    Key Record Dates
Last Update Posted: March 21, 2016
Last Verified: March 2016

Keywords provided by Pfizer:
fixed drug combination
Olmesartan medoxomil
uncontrolled hypertension
difficult to treat hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases
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