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

Primary Purpose

Essential Hypertension

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
olmesartan alone or in combination with hydrochlorothiazide
Sponsored by
Pfizer
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Essential Hypertension

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subject has mild to moderate hypertension Exclusion Criteria: History of secondary hypertension

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
August 29, 2005
Last Updated
December 3, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00139698
Brief Title
Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
Acronym
OSCAR
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
410 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
olmesartan alone or in combination with hydrochlorothiazide
Primary Outcome Measure Information:
Title
Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
Secondary Outcome Measure Information:
Title
Safety and tolerability of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has mild to moderate hypertension Exclusion Criteria: History of secondary hypertension
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Medellin
State/Province
Antioquia
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Barranquilla
State/Province
Atlantico
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cartagena
State/Province
Atlantico
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Bogota
State/Province
Cundinamarca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Cali
State/Province
Valle Del Cauca
Country
Colombia
Facility Name
Pfizer Investigational Site
City
Escobedo
State/Province
Guayas
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
Quito
State/Province
Pichincha
Country
Ecuador
Facility Name
Pfizer Investigational Site
City
NT
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Shatin, NT
Country
Hong Kong
Facility Name
Pfizer Investigational Site
City
Jakarta
ZIP/Postal Code
10430
Country
Indonesia
Facility Name
Pfizer Investigational Site
City
Jakarta
ZIP/Postal Code
11420
Country
Indonesia
Facility Name
Pfizer Investigational Site
City
Jakarta
Country
Indonesia
Facility Name
Pfizer Investigational Site
City
Surabaya
ZIP/Postal Code
60286
Country
Indonesia
Facility Name
Pfizer Investigational Site
City
Seremban
State/Province
Negeri Sembilan
ZIP/Postal Code
70300
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
Kuching
State/Province
Sarawak
ZIP/Postal Code
93586
Country
Malaysia
Facility Name
Pfizer Investigational Site
City
San Juan
State/Province
Metro Manila
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Quezon
Country
Philippines
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
Pfizer Investigational Site
City
Guei-Shan Shiang
State/Province
Tau-Yuan Shian
ZIP/Postal Code
333
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Kaohsiung
ZIP/Postal Code
813
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
106
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Taipei
ZIP/Postal Code
112
Country
Taiwan
Facility Name
Pfizer Investigational Site
City
Khet Rajathevee
State/Province
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Chiang Mai
ZIP/Postal Code
50200
Country
Thailand
Facility Name
Pfizer Investigational Site
City
Bornova/Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Haseki/Istanbul
ZIP/Postal Code
34390
Country
Turkey
Facility Name
Pfizer Investigational Site
City
Sihhiye/Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Pfizer Investigational Site
City
S¿hhiye/Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Pfizer Investigational Site

12. IPD Sharing Statement

Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0021002&StudyName=Olmesartan+Alone+or+in+Combination+With+Hydrochlorothiazide+in+Subjects+With+Mild+to+Moderate+Essential+Hypertension
Description
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Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension

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