Trial · NCT01062763
The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
NCT01062763, Phase 3, Completed, Ib Abildgaard Jacobsen; results first posted 2014-05-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension. Trials, record NCT01062763. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01062763
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- The Effect of Spironolactone on Blood Pressure in Type-2 Diabetics With Resistant Hypertension
- NCT number
- NCT01062763
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 119 participants, actual
- Lead sponsor
- Ib Abildgaard Jacobsen
- Conditions
- Arterial Hypertension, Hypertension, Resistant to Conventional Therapy, Diabetes Mellitus
- Interventions
- spironolactone, placebo
- First posted
- 2010-02-04
- Last updated
- 2014-05-08
- Other registries' IDs
- eudract:2009-017033-22
- Results first posted
- 2014-05-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change of of Systolic Blood Pressure | 4 months | Change of systolic blood pressure from baseline to study end at four months. |
| Primary | Change of Diastolic Blood Pressure | 4 months | Change of diastolic blood pressure from baseline to study end at four months. |
| Secondary | Adverse Effects | 4 months |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change of of Systolic Blood Pressure | 4 months | Analysis by intention to treat using LOCF | mm Hg | MEAN |
| SECONDARY | Adverse Effects | 4 months | Intention to treat | participants | NUMBER |
| PRIMARY | Change of Diastolic Blood Pressure | 4 months | Analyzed by intention to treat and last observation carried forward | mm Hg | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change of of Systolic Blood Pressure | Addition of Spironolactone | -9.6 | 95% Confidence Interval -12.8 to -6.3 | mm Hg | |
| Change of of Systolic Blood Pressure | Placebo | -0.7 | 95% Confidence Interval -3.3 to 2.0 | mm Hg | |
| Adverse Effects | Addition of Spironolactone | 4 | participants | ||
| Adverse Effects | Placebo | 0 | participants | ||
| Change of Diastolic Blood Pressure | Addition of Spironolactone | -3.9 | 95% Confidence Interval -6.0 to -2.0 | mm Hg | |
| Change of Diastolic Blood Pressure | Placebo | -0.3 | 95% Confidence Interval -1.8 to 1.3 | mm Hg |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Placebo | 58 | |
| Overall Study | STARTED | Addition of Spironolactone | 61 | |
| Overall Study | COMPLETED | Placebo | 55 | |
| Overall Study | COMPLETED | Addition of Spironolactone | 57 | |
| Overall Study | NOT COMPLETED | Placebo | 3 | |
| Overall Study | NOT COMPLETED | Addition of Spironolactone | 4 |
Source ClinicalTrials.gov
Adverse events2
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 |
|---|---|---|---|---|---|---|
| serious | Serious hyperkalemia | Blood and lymphatic system disorders | Addition of Spironolactone | 1 | 61 | 1 |
| serious | Serious hyperkalemia | Blood and lymphatic system disorders | Placebo | 0 | 58 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Addition of Spironolactone | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | Addition of Spironolactone | 0 | 61 |
| Total, other adverse events | Placebo | 0 | 58 |
| Total, serious adverse events | Addition of Spironolactone | 1 | 61 |
| Total, serious adverse events | Placebo | 0 | 58 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Addition of Spironolactone vs Placebo: Adverse Effects | Trial comparisons |
| Addition of Spironolactone vs Placebo: serious adverse events | 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/NCT01062763
GET https://conductscience.org/api/trials/v1/NCT01062763/registered