Trial · NCT01149486
Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
NCT01149486, Phase 1, Completed, Teva Pharmaceuticals USA; results first posted 2010-09-14
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions. Trials, record NCT01149486. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01149486
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Losartan Potassium/Hydrochlorothiazide 100/25 mg Tablets in Healthy Subjects Under Fasting Conditions
- NCT number
- NCT01149486
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 20 participants, actual
- Lead sponsor
- Teva Pharmaceuticals USA
- Conditions
- Healthy
- Interventions
- Losartan potassium/Hydrochlorothiazide, Hyzaar®
- First posted
- 2010-06-23
- Last updated
- 2010-12-08
- Results first posted
- 2010-09-14
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 48 hour period. | Bioequivalence based on Losartan Cmax. |
| Primary | AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 48 hour period. | Bioequivalence based on Losartan AUC0-t. |
| Primary | AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 48 hour period. | Bioequivalence based on Losartan AUC0-inf. |
| Primary | Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 48 hour period. | Bioequivalence based on Hydrochlorothiazide Cmax. |
| Primary | AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 48 hour period. | Bioequivalence based on Hydrochlorothiazide AUC0-t. |
| Primary | AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 48 hour period. | Bioequivalence based on Hydrochlorothiazide AUC0-inf. |
| Secondary | Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 48 hour period. | Informational comparison of Cmax values for the metabolite Losartan Carboxy Acid. |
| Secondary | AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 48 hour period. | Informational comparison of AUC0-t values for the metabolite Losartan Carboxy Acid. |
| Secondary | AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 48 hour period. | Informational comparison of AUC0-inf values for the metabolite Losartan Carboxy Acid. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng/mL | MEAN |
| PRIMARY | AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng*h/mL | MEAN |
| PRIMARY | AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng*h/mL | MEAN |
| PRIMARY | Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng/mL | MEAN |
| PRIMARY | AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng*h/mL | MEAN |
| PRIMARY | AUC0-inf of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng*h/mL | MEAN |
| SECONDARY | Cmax of Losartan Carboxy Acid(Maximum Observed Concentration of Drug Substance in Plasma) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng/mL | MEAN |
| SECONDARY | AUC0-t of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng*h/mL | MEAN |
| SECONDARY | AUC0-inf of Losartan Carboxy Acid(Area Under the Concentration-time Curve From Time Zero to Infinity) | Blood samples collected over a 48 hour period. | All participants that completed the study had their samples analyzed. | ng*h/mL | MEAN |
Source ClinicalTrials.gov
Results by group18
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) | Losartan/HCTZ (Test) | 509.63 | Standard Deviation 314.75 | ng/mL | |
| Cmax of Losartan(Maximum Observed Concentration of Drug Substance in Plasma) | Hyzaar® (Reference) | 538.11 | Standard Deviation 298.89 | ng/mL | |
| AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Losartan/HCTZ (Test) | 866.88 | Standard Deviation 366.15 | ng*h/mL | |
| AUC0-t of Losartan(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Hyzaar® (Reference) | 865.00 | Standard Deviation 362.86 | ng*h/mL | |
| AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) | Losartan/HCTZ (Test) | 880.15 | Standard Deviation 368.58 | ng*h/mL | |
| AUC0-inf of Losartan(Area Under the Concentration-time Curve From Time Zero to Infinity) | Hyzaar® (Reference) | 877.99 | Standard Deviation 362.75 | ng*h/mL | |
| Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) | Losartan/HCTZ (Test) | 177.63 | Standard Deviation 48.09 | ng/mL | |
| Cmax of Hydroclorothiazide(Maximum Observed Concentration of Drug Substance in Plasma) | Hyzaar® (Reference) | 161.56 | Standard Deviation 53.75 | ng/mL | |
| AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Losartan/HCTZ (Test) | 1057.58 | Standard Deviation 231.26 | ng*h/mL | |
| AUC0-t of Hydrochlorothiazide(Area Under the Concentration-time Curve From Time Zero to Time of Last Measurable Concentration) | Hyzaar® (Reference) | 1001.54 | Standard Deviation 236.00 | ng*h/mL |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| First Intervention | STARTED | Losartan/HCTZ (Test) First | 10 | |
| First Intervention | STARTED | Hyzaar® (Reference) First | 10 | |
| First Intervention | COMPLETED | Losartan/HCTZ (Test) First | 10 | |
| First Intervention | COMPLETED | Hyzaar® (Reference) First | 9 | |
| First Intervention | NOT COMPLETED | Losartan/HCTZ (Test) First | 0 | |
| First Intervention | NOT COMPLETED | Hyzaar® (Reference) First | 1 | |
| Washout of 7 Days | STARTED | Losartan/HCTZ (Test) First | 10 | |
| Washout of 7 Days | STARTED | Hyzaar® (Reference) First | 9 | |
| Washout of 7 Days | COMPLETED | Losartan/HCTZ (Test) First | 10 | |
| Washout of 7 Days | COMPLETED | Hyzaar® (Reference) First | 9 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events18
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 | Headache | General disorders | Losartan/HCTZ (Test) | 3 | 20 | 3 |
| other | Headache | General disorders | Hyzaar® (Reference) | 3 | 20 | 3 |
| other | Pharyngitis | General disorders | Losartan/HCTZ (Test) | 0 | 20 | 0 |
| other | Pharyngitis | General disorders | Hyzaar® (Reference) | 1 | 20 | 1 |
| other | Dizziness | General disorders | Losartan/HCTZ (Test) | 1 | 20 | 1 |
| other | Dizziness | General disorders | Hyzaar® (Reference) | 1 | 20 | 2 |
| other | Sweaty | General disorders | Losartan/HCTZ (Test) | 1 | 20 | 1 |
| other | Sweaty | General disorders | Hyzaar® (Reference) | 0 | 20 | 0 |
| other | Purpura | General disorders | Losartan/HCTZ (Test) | 1 | 20 | 1 |
| other | Purpura | General disorders | Hyzaar® (Reference) | 0 | 20 | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losartan/HCTZ (Test) | ||
| Total, all-cause mortality | Hyzaar® (Reference) | ||
| Total, other adverse events | Losartan/HCTZ (Test) | 3 | 20 |
| Total, other adverse events | Hyzaar® (Reference) | 6 | 20 |
| Total, serious adverse events | Losartan/HCTZ (Test) | 0 | 20 |
| Total, serious adverse events | Hyzaar® (Reference) | 0 | 20 |
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 (Test) vs Hyzaar® (Reference): 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/NCT01149486
GET https://conductscience.org/api/trials/v1/NCT01149486/registered