Trial · NCT06275763
Registered outcomes29
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 20 of 29
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Patients with uncontrolled BP on ABPM | First week of the patients' participation in the study | Percentage of patients with uncontrolled BP confirmed on ABPM (24h mean, SBP ≥125 mm Hg or DBP ≥80 mm Hg) |
| Primary | Patients with controlled BP after 12 weeks on triple SPC | Next 12 weeks of the patients' participation in the study | Percentage of patients with controlled BP after 12 weeks of treatment with triple SPC, confirmed on ABPM (24h mean, SBP \<125 mm Hg and DBP \<80 mm Hg) - as the efficacy of the treatment strategy (switching ineffective treatment to triple SPC) - the whole group and P+I+A and E+H+A groups separetly. |
| Primary | Systolic BP reduction on 4th antihypertensive drug | Last 24 weeks of the patients' participation in the study | Magnitude of reduction of SBP on ABPM (24h mean) after 12 weeks of treatment - comparison of eplerenone vs spironolactone and torasemide vs spironolactone. |
| Secondary | Percentage of patients with BP controlled confirmed by HBPM | First week of the patients' participation in the study | Percentage of patients with BP controlled confirmed by HBPM (mean over the period of 6 days, SBP ≥130 mm Hg or DBP ≥80 mm Hg) |
| Secondary | Consistency of the rate of uncontrolled BP | First week of the patients' participation in the study | Consistency of the rate of uncontrolled BP between ABPM and HBPM |
| Secondary | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM | Next 12 weeks of the patients' participation in the study | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM (SBP \<130 mm Hg and DBP \<80 mm Hg). |
| Secondary | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM | Next 12 weeks of the patients' participation in the study | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM (mean over 6 days, SBP \<130 mm Hg and DBP \<80 mm Hg). |
| Secondary | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM | Next 12 weeks of the patients' participation in the study | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM in daytime (SBP \<135 mm Hg and DBP \<85 mm Hg) and nighttime (SBP \<120 mm Hg and DBP \<70 mm Hg) reading. |
| Secondary | Percentage of patients requiring an increase in the dose | Next 12 weeks of the patients' participation in the study | Percentage of patients requiring an increase in the dose of drugs used in the whole group and in the patients treated with P+I+A and O+H+A separately. |
| Secondary | Consistency of the rate of uncontrolled BP | Next 12 weeks of the patients' participation in the study | Consistency of the rate of uncontrolled BP between ABPM, HBPM and OBPM. |
| Secondary | The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks | Next 12 weeks of the patients' participation in the study | The magnitude of the decrease in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks of treatment in the whole group and in the patients treated with P+I+A and O+H+A separately. |
| Secondary | The magnitude of changes in HBPM and ABPM derived indices after 12 weeks | Next 12 weeks of the patients' participation in the study | The magnitude of changes in HBPM and ABPM derived indices after 12 weeks of treatment in the whole group and in the patients treated with P+I+A and O+H+A separately. |
| Secondary | Phase C | Last 24 weeks of the patients' participation in the study | * Changes of SBP on ABPM (24h mean) after 12 weeks of treatment in patients receiving spironolactone, eplerenone or torasemide as compared against baseline. * Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM (SBP \<130 mm Hg and DBP \<80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group. * Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM (mean over 6 days, SBP \<130 mm Hg and DBP \<80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group. * Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM, in 24h mean (SBP \<125 mm Hg and DBP \<80 mm Hg), daytime (SBP \<135 mm Hg and DBP \<85 mm Hg) and nighttime (SBP \<120 mm Hg and DBP \<70 mm Hg) readings - comparison of eplerenone / torasemide groups against the spironolactone group. |
| Secondary | Changes of SBP on ABPM (24h mean) after 12 weeks of treatment | Last 24 weeks of the patients' participation in the study | Changes of SBP on ABPM (24h mean) after 12 weeks of treatment in patients receiving spironolactone, eplerenone or torasemide as compared against baseline. |
| Secondary | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM | Last 24 weeks of the patients' participation in the study | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by OBPM (SBP \<130 mm Hg and DBP \<80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group. |
| Secondary | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM | Last 24 weeks of the patients' participation in the study | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by HBPM (mean over 6 days, SBP \<130 mm Hg and DBP \<80 mm Hg) - comparison of eplerenone / torasemide groups against the spironolactone group. |
| Secondary | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM | Last 24 weeks of the patients' participation in the study | Percentage of patients with controlled BP after 12 weeks of treatment, confirmed by ABPM, in 24h mean (SBP \<125 mm Hg and DBP \<80 mm Hg), daytime (SBP \<135 mm Hg and DBP \<85 mm Hg) and nighttime (SBP \<120 mm Hg and DBP \<70 mm Hg) readings - comparison of eplerenone / torasemide groups against the spironolactone group. |
| Secondary | Phase C continuation | Last 24 weeks of the patients' participation in the study | Consistency of the rate of controlled BP between ABPM, HBPM and OBPM (after 12 weeks of treatment). |
| Secondary | Phase C continuation | Last 24 weeks of the patients' participation in the study | Changes in SBP and DBP on OBPM, ABPM and HBPM after 12 weeks of treatment - comparison of eplerenone / torasemide groups against the spironolactone group and comparison of each of the studied drug groups against baseline. |
| Secondary | Changes in HBPM and ABPM derived indices after 12 weeks - comparison of treatment groups | Last 24 weeks of the patients' participation in the study | Changes in HBPM and ABPM derived indices after 12 weeks of treatment - comparison of eplerenone / torasemide groups against the spironolactone group and comparison of each of the studied drug groups against baseline |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
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.
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