Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

Condition(s) targeted: Hypertension

Intervention: Amlodipine + Olmesartan medoxomil (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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

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

Study design: Time Perspective: Prospective

Primary outcome: Number of participants with each Adverse Events being reported

Secondary outcome:

Efficacy: change from baseline in mean SBP and DBP at week 12 using the LOCF

Efficacy: change from baseline in mean SBP and DBP at week 4, 8 and 12 without LOCF

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

Detailed description: To determine safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Filipino hypertensive patients. Non-probability sample

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

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, Manila, Philippines

Metropolitan Medical Center Institutional Review Board, 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

Lorma Medical Center, San Fernando City, La Union 2500, Philippines

Holy Child Hospital, Taclobo, Dumaguete City, Negros Oriental, Philippines

To obtain contact information for a study center near you, click here.

Starting date: June 2010
Last updated: April 1, 2015