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

Tracking Information

First Received Date ^ICMJE

November 20, 2008

Last Updated Date

December 21, 2009

Start Date ^ICMJE

July 2007

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00796159 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Blood Pressure [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Post-Marketing Surveillance Of Olmesartan Medoxomil In Combination With Hydrochlorothiazide

Official Title ^ICMJE

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

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

Detailed Description

Non Probability Sampling

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Filipino patients with Uncontrolled Mild to Moderate Essential Hypertension

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Drug: Olmesartan medoxomil

olmesartan medoxomil 20 mg and HCTZ 12.5 mg

Study Group/Cohort (s)

Olmesartan medoxomil + HCTZ

Intervention: Drug: Olmesartan medoxomil

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

1723

Completion Date

December 2008

Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT00796159

Other Study ID Numbers ^ICMJE

A0021004

Has Data Monitoring Committee

Responsible Party

Director, Clinical Trial Disclosure Group, Pfizer, Inc.

Study Sponsor ^ICMJE

Pfizer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Pfizer CT.gov Call Center

Pfizer

Information Provided By

Pfizer

Verification Date

December 2009

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

To Top