We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Sponsor:
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

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, Learn About Clinical Studies.


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
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

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


  Show 57 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
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:
Hypertension
fixed drug combination
Filipinos
Amlodipine
Olmesartan medoxomil
uncontrolled hypertension
difficult to treat hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Olmesartan
Amlodipine
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