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)
2 other identifiers
interventional
11
0 countries
N/A
Brief Summary
Evaluate blood pressure after 6 weeks of treatment with COZAAR plus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 hypertension
Started Mar 2006
Shorter than P25 for phase_3 hypertension
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 13, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 30, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2006
CompletedFirst Submitted
Initial submission to the registry
March 16, 2007
CompletedFirst Posted
Study publicly available on registry
March 19, 2007
CompletedAugust 15, 2024
February 1, 2022
7 months
March 16, 2007
August 13, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Change of diastolic blood pressure after 6 weeks of treatment with cozaar plus
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Organon and Colead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Merck Sharp & Dohme LLC
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2007
First Posted
March 19, 2007
Study Start
March 13, 2006
Primary Completion
September 30, 2006
Study Completion
September 30, 2006
Last Updated
August 15, 2024
Record last verified: 2022-02