Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

This study is enrolling participants by invitation only.

First Received: November 20, 2008 Last Updated: January 29, 2009 History of Changes

Sponsored by:	Pfizer
Information provided by:	Pfizer
ClinicalTrials.gov Identifier:	NCT00796159

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 IV

MedlinePlus related topics: High Blood Pressure

Drug Information available for: Hydrochlorothiazide Olmesartan Olmesartan medoxomil

U.S. FDA Resources

Study Type:	Observational
Study Design:	Case-Only, 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 20 Mg In Combination With 12.5 Mg Of Hydrochlorothiazide In Subjects With Mild To Moderate Essential Hypertension

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	3000
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2010
Estimated Primary Completion Date:	October 2010 (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:	Pfizer, Inc. ( Director, Clinical Trial Disclosure Group )
Study ID Numbers:	A0021004
Study First Received:	November 20, 2008
Last Updated:	January 29, 2009
ClinicalTrials.gov Identifier:	NCT00796159 History of Changes
Health Authority:	Philippines: Bureau of Food and Drugs

Keywords provided by Pfizer:

Efficacy; Tolerability; Safety; Essential Hypertension

Study placed in the following topic categories:

Angiotensin II Type 1 Receptor Blockers
Essential Hypertension
Sodium Chloride Symporter Inhibitors
Diuretics
Vascular Diseases
Olmesartan medoxomil

Cardiovascular Agents
Angiotensin II
Antihypertensive Agents
Hydrochlorothiazide
Hypertension

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Diuretics
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Vascular Diseases
Olmesartan medoxomil
Cardiovascular Agents
Antihypertensive Agents

Hydrochlorothiazide
Pharmacologic Actions
Angiotensin II Type 1 Receptor Blockers
Membrane Transport Modulators
Natriuretic Agents
Therapeutic Uses
Cardiovascular Diseases
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009