Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
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ClinicalTrials.gov Identifier: NCT00953680 |
Recruitment Status :
Completed
First Posted : August 6, 2009
Results First Posted : July 16, 2010
Last Update Posted : February 9, 2022
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Sponsor:
Organon and Co
Information provided by (Responsible Party):
Organon and Co
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Hypertension |
Interventions |
Drug: losartan potassium (+) hydrochlorothiazide (HCTZ) Drug: losartan potassium Drug: hydrochlorothiazide (HCTZ) |
Enrollment | 77 |
Participant Flow
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet |
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Single dose losartan 100 mg and hydrochlorothiazide (HCTZ) 12.5 mg combination tablet then a single dose losartan 100 mg tablet + HCTZ 12.5 mg capsule | Single dose losartan 100 mg tablet + hydrochlorothiazide (HCTZ) 12.5 mg capsule then a single dose losartan 100 mg and HCTZ 12.5 mg combination tablet |
Period Title: Period 1 | ||
Started | 38 | 39 |
Completed | 38 | 38 |
Not Completed | 0 | 1 |
Reason Not Completed | ||
Withdrawal by Subject | 0 | 1 |
Period Title: Period 2 | ||
Started | 38 | 38 |
Completed | 38 | 38 |
Not Completed | 0 | 0 |
Baseline Characteristics
Arm/Group Title | All Participants | |
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All randomized patients | |
Overall Number of Baseline Participants | 77 | |
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[Not Specified]
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Age, Continuous
Mean (Full Range) Unit of measure: Years |
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Number Analyzed | 77 participants | |
33.87
(18 to 45)
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 77 participants | |
Female |
46 59.7%
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Male |
31 40.3%
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Height
Mean (Full Range) Unit of measure: Centimeters |
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Number Analyzed | 77 participants | |
166.81
(152 to 191)
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Weight
Mean (Full Range) Unit of measure: Kilograms |
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Number Analyzed | 77 participants | |
73.01
(50 to 99.1)
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Outcome Measures
Adverse Events
Limitations and Caveats
PK analyses included complete data from 75 subjects. 3 losartan/E-3174 concentrations from 3 different subjects were excluded from analyses due to gross deviations; 75 minutes-Treatment B, 75 minutes-Treatment A, & 15 minutes-Treatment A.
More Information
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts
the PI's rights to discuss or publish trial results after the trial is completed.
Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Name/Title: | Executive Vice President, Clinical and Quantitative Sciences |
Organization: | Merck Sharp & Dohme Corp |
Phone: | 1-800-672-6372 |
Responsible Party: | Organon and Co |
ClinicalTrials.gov Identifier: | NCT00953680 |
Other Study ID Numbers: |
0954A-306 2009_628 |
First Submitted: | August 4, 2009 |
First Posted: | August 6, 2009 |
Results First Submitted: | May 13, 2010 |
Results First Posted: | July 16, 2010 |
Last Update Posted: | February 9, 2022 |