Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

Hypertension Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01200407
• Other study ID #: B1581001
• Status: Terminated
• Start date: June 9, 2010
• Est. completion date: January 4, 2014

Study information

• Verified date: July 2021
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 615
• Est. completion date: January 4, 2014
• Est. primary completion date: January 4, 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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

Locations

Country	Name	City	State
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	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
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	Armed Forces of the Philippines Medical Center	Quezon City
Philippines	Private Clinic	Quezon City
Philippines	Angono Medics	Rizal
Philippines	Lorma Medical Center	San Fernando City	LA Union
Philippines	Private Clinic	San Juan
Philippines	Private Clinic	Tacloban
Philippines	Holy Child Hospital	Taclobo, Dumaguete City	Negros Oriental
Philippines	Private Clinic	Taguig
Philippines	Private Clinic	Tarlac
Philippines	Private Clinic	Tugegarao
Philippines	Priavte Clinic	Tuguegarao City
Philippines	Private Clinic	Tuguegarao City

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

Philippines, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)	An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last study drug administration (Week 12) that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.	Baseline up to 28 days after last study drug administration (Week 12)
Primary	Change From Baseline in SBP and DBP at Week 12 With Last Observation Carried Forward (LOCF)		Baseline, Week 12
Secondary	Change From Baseline in Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP) at Weeks 4, 8 and 12 Without (w/o) LOCF		Baseline, Week 4, Week 8, Week 12
Secondary	Percentage of Participants Achieving JNC VII Recommended Blood Pressure Goal at Week 12 With LOCF	Based on JNC VII, the ultimate public health goal of antihypertensive therapy is to reduce cardiovascular and renal morbidity and mortality. The JNC VII recommended BP goal is <140/90 mmHg and <130/80 mmHg for participants with diabetes.	Baseline, Week 12

External Links

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