An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension (0954A-325)
Primary Purpose
Hypertension
Status
Terminated
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MK0954, losartan potassium / Duration of Treatment - 12 weeks
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension
Eligibility Criteria
Inclusion Criteria:
- Patient treated with valsartan 80mg or irbesartan 150mg or vandesartan 8mg for at least 4 weeks prior to visit 1
- Patient with systolic blood pressure between 140 to 159 mmhg and diastolic pressure between 90 to 99mmhg taken at visit 1
Exclusion Criteria:
- History of angina pectoris that has not been stabilized in the past 6 weeks
- History of clinically significant abnormal lab results or diseases
- Myocardial infarction within the past 6 months
- Stroke in the past 6 months
Sites / Locations
Outcomes
Primary Outcome Measures
Change of diastolic blood pressure after 6 weeks of treatment with cozaar plus
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00449111
Brief Title
An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension (0954A-325)
Official Title
An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Terminated
Study Start Date
March 13, 2006 (Actual)
Primary Completion Date
September 30, 2006 (Actual)
Study Completion Date
September 30, 2006 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
5. Study Description
Brief Summary
Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
11 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
MK0954, losartan potassium / Duration of Treatment - 12 weeks
Primary Outcome Measure Information:
Title
Change of diastolic blood pressure after 6 weeks of treatment with cozaar plus
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patient treated with valsartan 80mg or irbesartan 150mg or vandesartan 8mg for at least 4 weeks prior to visit 1
Patient with systolic blood pressure between 140 to 159 mmhg and diastolic pressure between 90 to 99mmhg taken at visit 1
Exclusion Criteria:
History of angina pectoris that has not been stabilized in the past 6 weeks
History of clinically significant abnormal lab results or diseases
Myocardial infarction within the past 6 months
Stroke in the past 6 months
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Monitor
Organizational Affiliation
Merck Sharp & Dohme LLC
Official's Role
Study Director
12. IPD Sharing Statement
Links:
URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Description
Click here to access a synopsis of the study results.
Available IPD and Supporting Information:
Available IPD/Information Type
CSR Synopsis
Available IPD/Information URL
http://www.merck.com/clinical-trials/policies-perspectives.html
Learn more about this trial
An Open Label Study to Assess the Efficacy, Safety and Tolerability of COZAAR Plus (Losartan Potassium 50mg/Hydrochlorothiazide 12.5mg) Possibly Titrated up to COZAAR Plus-F (Losartan Potassium 100mg/Hydrochlorothiazide 25mg) in Patients With Essential Hypertension (0954A-325)
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