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

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: NCT00139698
Recruitment Status : Completed
First Posted : August 31, 2005
Last Update Posted : December 5, 2018
Sponsor:
Information provided by:
Pfizer

Tracking Information
First Submitted Date  ICMJE August 29, 2005
First Posted Date  ICMJE August 31, 2005
Last Update Posted Date December 5, 2018
Study Start Date  ICMJE September 2005
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Efficacy of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00139698 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 29, 2005)
Safety and tolerability of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Olmesartan Alone or in Combination With Hydrochlorothiazide in Subjects With Mild to Moderate Essential Hypertension
Official Title  ICMJE 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
Brief Summary Efficacy, tolerability and safety of olmesartan alone or in combination with hydrochlorothiazide in the treatment of mild to moderate essential hypertension
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE Drug: olmesartan alone or in combination with hydrochlorothiazide
Study Arms  ICMJE Not Provided
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
 (submitted: August 29, 2005)
410
Original Enrollment  ICMJE Same as current
Study Completion Date  ICMJE July 2006
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject has mild to moderate hypertension

Exclusion Criteria:

  • History of secondary hypertension
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Ecuador,   Hong Kong,   Indonesia,   Malaysia,   Philippines,   Singapore,   Taiwan,   Thailand,   Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00139698
Other Study ID Numbers  ICMJE A0021002
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date December 2018

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