Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

This study has been completed.
Information provided by (Responsible Party):
Pfizer Identifier:
First received: August 25, 2010
Last updated: April 1, 2015
Last verified: April 2015
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
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 ]

Enrollment: 656
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 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

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

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 identifier: NCT01200407

  Show 57 Study Locations
Sponsors and Collaborators
Study Director: Pfizer Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer Identifier: NCT01200407     History of Changes
Other Study ID Numbers: B1581001
Study First Received: August 25, 2010
Last Updated: April 1, 2015
Health Authority: Philippines: Ethics Committee

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

Additional relevant MeSH terms:
Cardiovascular Diseases
Vascular Diseases
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 processed this record on November 25, 2015