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Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

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: NCT00796159
Recruitment Status : Completed
First Posted : November 24, 2008
Last Update Posted : December 23, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Hypertension Drug: Olmesartan medoxomil Phase 4

Detailed Description:
Non Probability Sampling

Study Design

Study Type : Observational
Actual Enrollment : 1723 participants
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
Study Start Date : July 2007
Primary Completion Date : December 2008
Study Completion Date : December 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Olmesartan medoxomil + HCTZ Drug: Olmesartan medoxomil
olmesartan medoxomil 20 mg and HCTZ 12.5 mg


Outcome Measures

Primary Outcome Measures :
  1. Safety (Adverse Events) [ Time Frame: 4 weeks ]

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: 4 weeks ]

Eligibility Criteria

Information from the National Library of Medicine

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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 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

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): NCT00796159


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

Additional Information:
Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00796159     History of Changes
Other Study ID Numbers: A0021004
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: December 23, 2009
Last Verified: December 2009

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

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