Trial · NCT05110898
Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.
NCT05110898, Phase 3, Unknown, Brainfarma Industria Química e Farmacêutica S/A
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension. Trials, record NCT05110898. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05110898
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of the Fixed-dose Combination of Olmesartan + Indapamide When Compared to the Isolated Drugs in the Treatment of Hypertension.
- NCT number
- NCT05110898
- Status
- Unknown
- Phases
- Phase 3
- Enrollment
- 400 participants, estimated
- Lead sponsor
- Brainfarma Industria Química e Farmacêutica S/A
- Conditions
- Hypertension, Hypertension,Essential
- Interventions
- fixed-dose of olmesartan 20mg/40 mg + indapamide 1,5 mg, Isolated drugs Olmesartan (20 mg or 40 mg) and Indapamide (1,5 mg)
- First posted
- 2021-11-08
- Last updated
- 2022-03-21
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Non-inferiority of fixed dose association of olmesartan + indapamide compared to the isolated drugs in the treatment of hypertension. | 12 weeks of treatment | To evaluate the non-inferiority of the fixed dose association of olmesartan + indapamide to the isolated drugs in the change of the diastolic blood pressure from baseline to 12 week endpoint through Ambulatory Blood Pressure Monitoring. |
| Secondary | Diastolic Blood Pressure Control | 12 weeks of treatment | Proportion of participants achieving a diastolic blood pressure below 90 mmHg |
| Secondary | Systolic Blood Pressure Control | 12 weeks of treatment | Proportion of participants achieving a systolic blood pressure below 140 mmHg |
| Secondary | Proportion of systolic and diastolic treatment response | 12 weeks of treatment | Proportion of participants achieving a systolic blood pressure reduction greater than 20 mmHg and a diastolic blood pressure reduction greater than 10 mmHg. |
| Secondary | Systolic and diastolic blood pressure variation by ABPM exam | 12 weeks of treatment | Systolic and diastolic blood pressure variation by ABPM examination from the baseline period compared to the result after 12 weeks of treatment; |
| Secondary | Patients responses to the treatment satisfaction questionnaire | 12 weeks of treatment | Patients responses to a questionnaire regarding if they are satisfied with the treatment. |
| Secondary | Tolerability and occurrence of adverse events (AEs) during the study period. | 12 weeks of treatment | Tolerability and occurrence of adverse events (AEs) during the study period in both study arms. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT05110898
GET https://conductscience.org/api/trials/v1/NCT05110898/registered