Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension (OSCAR)

December 3, 2018 updated by: Pfizer

A Phase III, Multicenter, Open-Label, Dose-Titrating, 16-Week Study Evaluating The Efficacy, Tolerability and Safety of Olmesartan Medoxomil 20 Mg and 40 Mg Alone or in Combination With 12.5 Mg to 25 Mg of Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

Study Overview

Status

Completed

Conditions

Essential Hypertension

Intervention / Treatment

Drug: olmesartan alone or in combination with hydrochlorothiazide

Study Type

Interventional

Enrollment

410

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

- - - Pfizer Investigational Site
Colombia
- Antioquia
  - Medellin, Antioquia, Colombia
    - Pfizer Investigational Site
- Atlantico
  - Barranquilla, Atlantico, Colombia
    - Pfizer Investigational Site
  - Cartagena, Atlantico, Colombia
    - Pfizer Investigational Site
- Cundinamarca
  - Bogota, Cundinamarca, Colombia
    - Pfizer Investigational Site
- Valle Del Cauca
  - Cali, Valle Del Cauca, Colombia
    - Pfizer Investigational Site
Ecuador
- Guayas
  - Escobedo, Guayas, Ecuador
    - Pfizer Investigational Site
- Pichincha
  - Quito, Pichincha, Ecuador
    - Pfizer Investigational Site
Hong Kong
- - NT, Hong Kong
    - Pfizer Investigational Site
  - Shatin, NT, Hong Kong
    - Pfizer Investigational Site
Indonesia
- - Jakarta, Indonesia, 10430
    - Pfizer Investigational Site
  - Jakarta, Indonesia, 11420
    - Pfizer Investigational Site
  - Jakarta, Indonesia
    - Pfizer Investigational Site
  - Surabaya, Indonesia, 60286
    - Pfizer Investigational Site
Malaysia
- Negeri Sembilan
  - Seremban, Negeri Sembilan, Malaysia, 70300
    - Pfizer Investigational Site
- Sarawak
  - Kuching, Sarawak, Malaysia, 93586
    - Pfizer Investigational Site
Philippines
- - Quezon, Philippines
    - Pfizer Investigational Site
- Metro Manila
  - San Juan, Metro Manila, Philippines
    - Pfizer Investigational Site
Singapore
- - Singapore, Singapore, 119074
    - Pfizer Investigational Site
  - Singapore, Singapore, 169608
    - Pfizer Investigational Site
Taiwan
- - Kaohsiung, Taiwan, 813
    - Pfizer Investigational Site
  - Taipei, Taiwan, 112
    - Pfizer Investigational Site
  - Taipei, Taiwan, 106
    - Pfizer Investigational Site
- Tau-Yuan Shian
  - Guei-Shan Shiang, Tau-Yuan Shian, Taiwan, 333
    - Pfizer Investigational Site
Thailand
- - Bangkok, Thailand, 10400
    - Pfizer Investigational Site
  - Bangkok, Thailand, 10700
    - Pfizer Investigational Site
  - Chiang Mai, Thailand, 50200
    - Pfizer Investigational Site
- Bangkok
  - Khet Rajathevee, Bangkok, Thailand, 10400
    - Pfizer Investigational Site
Turkey
- - Bornova/Izmir, Turkey, 35100
    - Pfizer Investigational Site
  - Haseki/Istanbul, Turkey, 34390
    - Pfizer Investigational Site
  - Sihhiye/Ankara, Turkey, 06100
    - Pfizer Investigational Site
  - SÂ¿hhiye/Ankara, Turkey, 06100
    - Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Subject has mild to moderate hypertension

Exclusion Criteria:

History of secondary hypertension

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: TREATMENT
Allocation: NON_RANDOMIZED
Interventional Model: SINGLE_GROUP
Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

Secondary Outcome Measures

Outcome Measure
Safety and tolerability of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

To obtain contact information for a study center near you, click here.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2005

Study Completion

July 1, 2006

Study Registration Dates

First Submitted

August 29, 2005

First Submitted That Met QC Criteria

August 29, 2005

First Posted (ESTIMATE)

August 31, 2005

Study Record Updates

Last Update Posted (ACTUAL)

December 5, 2018

Last Update Submitted That Met QC Criteria

December 3, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

A0021002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.