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Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00796159
First received: November 20, 2008
Last updated: December 21, 2009
Last verified: December 2009
History of Changes
  Purpose

This is a Post-Marketing Surveillance study evaluating the Efficacy, Tolerability and Safety of Olmesartan medoxomil 20 mg in combination with 12.5 MG of hydrochlorothiazide in subjects with mild to moderate essential hypertension


Condition Intervention Phase
Hypertension
 Drug: Olmesartan medoxomil
 Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Cross-Sectional
Official Title: A Post Marketing Surveillance, Multicenter, Open-Label, Dose-Titrating, 4-Week Study Evaluating The Efficacy, Tolerability And Safety Of Olmesartan Medoxomil 20mg In Combination With 12.5mg Hydrochlorothiazide In Subjects With Stage 1 To Stage 2 Hypertension

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Safety (Adverse Events) [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Enrollment: 1723
Study Start Date: July 2007
Study Completion Date: December 2008
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Olmesartan medoxomil + HCTZ Drug: Olmesartan medoxomil
olmesartan medoxomil 20 mg and HCTZ 12.5 mg

Detailed Description:

Non Probability Sampling

  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 patients with Uncontrolled Mild to Moderate Essential Hypertension

Criteria

Inclusion Criteria:

  • Male and Female patients 18 to 65 y/old
  • Patient previously taking low-dose medoxomil or any other ARB alone with uncontrolled BP
  • Patient with uncontrolled mild to moderate hypertension (SBP>= 140 and <=179 mmHg OR DBP of >=90 and <=109 mmHg)

Exclusion Criteria:

  • Pregnant of Lactating women
  • History of secondary hypertension
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796159

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: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00796159     History of Changes
Other Study ID Numbers: A0021004
Study First Received: November 20, 2008
Last Updated: December 21, 2009
Health Authority: Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:
Efficacy; Tolerability; Safety; Essential Hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Olmesartan medoxomil
Olmesartan
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
 Pharmacologic Actions
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on June 18, 2013