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Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients

This study is currently recruiting participants.
Verified May 2013 by Pfizer
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01200407
First received: August 25, 2010
Last updated: May 12, 2013
Last verified: May 2013
History of Changes

August 25, 2010
May 12, 2013
June 2010
July 2015   (final data collection date for primary outcome measure)
Number of participants with each Adverse Events being reported [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01200407 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 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 ]
Not Provided
Not Provided
 
Amlodipine And Olmesartan Medoxomil In Hypertensive Filipino Patients
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

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

To determine safety, tolerability and efficacy of Amlodipine and Olmesartan medoxomil among Filipino hypertensive patients. Non-probability sample
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Filipino Hypertensive patients ages 18-65 years old
Hypertension
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
Filipino Hypertensive patients
Intervention: Drug: Amlodipine + Olmesartan medoxomil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
July 2015
July 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact: Pfizer CT.gov Call Center 1-800-718-1021
Philippines
 
NCT01200407
B1581001
No
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP