Trial · NCT00953680
Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
NCT00953680, Phase 1, Completed, Organon and Co; results first posted 2010-07-16
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306). Trials, record NCT00953680. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00953680
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Bioequivalence of Losartan and Hydrochlorothiazide (HCTZ) Combination Tablet and Coadministration of Its Components (0954A-306)
- NCT number
- NCT00953680
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 77 participants, actual
- Lead sponsor
- Organon and Co
- Conditions
- Hypertension
- Interventions
- losartan potassium (+) hydrochlorothiazide (HCTZ), losartan potassium, hydrochlorothiazide (HCTZ)
- First posted
- 2009-08-06
- Last updated
- 2022-02-09
- Results first posted
- 2010-07-16
- 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.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Area Under the Curve (AUC(0 to Infinity)) of Losartan | 0 to 36 Hours Post Dose | |
| Primary | Peak Plasma Concentration (Cmax) for Losartan | 36 Hours Post Dose | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing. |
| Primary | Area Under the Curve (AUC(0 to Infinity)) of HCTZ | 0 to 30 Hours Post Dose | Plasma Area Under the Curve, a measure of drug exposure following dosing |
| Primary | Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ | 30 Hours Post Dose | Peak Plasma Concentration (Cmax), or maximal concentration of drug following dosing |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Area Under the Curve (AUC(0 to Infinity)) of Losartan | 0 to 36 Hours Post Dose | Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses. | ng*hr/mL | LEAST_SQUARES_MEAN |
| PRIMARY | Peak Plasma Concentration (Cmax) for Losartan | 36 Hours Post Dose | Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses. | ng/mL | LEAST_SQUARES_MEAN |
| PRIMARY | Area Under the Curve (AUC(0 to Infinity)) of HCTZ | 0 to 30 Hours Post Dose | Pharmacokinetic (PK) results included complete data from 75 of 77 subjects (with 1 replacement). Partial data from 1 subject were not analyzed. Plasma concentrations for another subject were undetectable following 1 treatment, with partial data excluded from analyses. | ng*hr/mL | LEAST_SQUARES_MEAN |
| PRIMARY | Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ | 30 Hours Post Dose | Pharmacokinetic (PK) results were based on data from the 20 subjects who had blood drawn for the HCTZ assay. These 20 subjects were selected as the first 10 subjects from each treatment sequence who completed both periods of the study. | ng/mL | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Area Under the Curve (AUC(0 to Infinity)) of Losartan | Losartan-HCTZ Combination Tablet | 1018.1 | Standard Deviation 382.5 | ng*hr/mL | |
| Area Under the Curve (AUC(0 to Infinity)) of Losartan | Losartan Tablet + HCTZ Capsule | 1024.9 | Standard Deviation 354.6 | ng*hr/mL | |
| Peak Plasma Concentration (Cmax) for Losartan | Losartan-HCTZ Combination Tablet | 532.7 | Standard Deviation 334.9 | ng/mL | |
| Peak Plasma Concentration (Cmax) for Losartan | Losartan Tablet + HCTZ Capsule | 637.9 | Standard Deviation 425.3 | ng/mL | |
| Area Under the Curve (AUC(0 to Infinity)) of HCTZ | Losartan-HCTZ Combination Tablet | 462.08 | Standard Deviation 144.72 | ng*hr/mL | |
| Area Under the Curve (AUC(0 to Infinity)) of HCTZ | Losartan Tablet + HCTZ Capsule | 499.90 | Standard Deviation 133.46 | ng*hr/mL | |
| Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ | Losartan-HCTZ Combination Tablet | 76.15 | Standard Deviation 39.55 | ng/mL | |
| Peak Plasma Concentration (Cmax) of HCTZ Following Single Dose Administration of Losartan/HCTZ or Losartan and HCTZ | Losartan Tablet + HCTZ Capsule | 81.76 | Standard Deviation 31.05 | ng/mL |
Source ClinicalTrials.gov
Participant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Period 1 | STARTED | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 38 | |
| Period 1 | STARTED | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 39 | |
| Period 1 | COMPLETED | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 38 | |
| Period 1 | COMPLETED | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 38 | |
| Period 1 | NOT COMPLETED | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 0 | |
| Period 1 | NOT COMPLETED | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 1 | |
| Period 2 | STARTED | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 38 | |
| Period 2 | STARTED | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 38 | |
| Period 2 | COMPLETED | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 38 | |
| Period 2 | COMPLETED | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 38 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events12
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 0 | 76 | |
| other | Nausea | Gastrointestinal disorders | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 1 | 77 | |
| other | Vomiting | Gastrointestinal disorders | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 1 | 76 | |
| other | Vomiting | Gastrointestinal disorders | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 1 | 77 | |
| other | Alanine Aminotransferase Increased | Investigations | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 1 | 76 | |
| other | Alanine Aminotransferase Increased | Investigations | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 0 | 77 | |
| other | Aspartate Aminotransferase Increased | Investigations | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 1 | 76 | |
| other | Aspartate Aminotransferase Increased | Investigations | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 0 | 77 | |
| other | Dizziness | Nervous system disorders | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 5 | 76 | |
| other | Dizziness | Nervous system disorders | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 3 | 77 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | ||
| Total, all-cause mortality | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | ||
| Total, other adverse events | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 12 | 76 |
| Total, other adverse events | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 10 | 77 |
| Total, serious adverse events | Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule | 0 | 38 |
| Total, serious adverse events | Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet | 0 | 39 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Losartan-HCTZ Combination Tablet/Losartan Tablet +HCTZ Capsule vs Losartan Tablet +HCTZ Capsule/Losartan-HCTZ Combination Tablet: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00953680
GET https://conductscience.org/api/trials/v1/NCT00953680/registered