Text Size

Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

This study is currently recruiting participants.
Verified June 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200407
First received: August 25, 2010
Last updated: June 13, 2013
Last verified: June 2013
History of Changes
  Purpose

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
Hypertension
 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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 3000
Study Start Date: June 2010
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: July 2015 (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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01200407

Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021

  Show 60 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
To obtain contact information for a study center near you, click here.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01200407     History of Changes
Other Study ID Numbers: B1581001
Study First Received: August 25, 2010
Last Updated: June 13, 2013
Health Authority: Philippines: Ethics Committee

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
Amlodipine
Olmesartan medoxomil
Olmesartan
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Vasodilator Agents
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 17, 2013