Trial · NCT00389168
Irbesartan and Atenolol in Hypertensive Heart Disease
NCT00389168, Phase 2, Phase 3, Completed, Karolinska Institutet; results first posted 2015-05-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Irbesartan and Atenolol in Hypertensive Heart Disease. Trials, record NCT00389168. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00389168
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Irbesartan and Atenolol in Hypertensive Heart Disease
- NCT number
- NCT00389168
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 115 participants, actual
- Lead sponsor
- Karolinska Institutet
- Conditions
- Hypertension
- Interventions
- Irbesartan, Atenolol
- First posted
- 2006-10-18
- Last updated
- 2015-05-05
- Results first posted
- 2015-05-05
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Changes in Left Ventricular Mass Index | Baseline and 48 weeks | Repeated measures multivariate analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks. Data are presented as left ventricular mass in gram (g) indexed for body mass index (in m\^2). |
| Secondary | Number of Participants With Serious Adverse Events | Treatment period was baseline to 48 weeks | Safety was assessed by non-directed questions, and all observed and volunteered adverse events were recorded at each study visit. Serious adverse events were defined by, and reported according to the regulations of good clinical practice (GCP). none were considered related to the study medication. |
| Secondary | Left Ventricular Diastolic Function Assessed by the E/A Ratio | Baseline to 48 weeks | Changes in left ventricular diastolic function from baseline to week 48 will be evaluated as the difference in E/A ratio. Conventional pulsed wave Doppler echocardiography was used for recordings of mitral inflow in. The peak of early (E) and late (A) mitral flow velocities were measured, and the E/A-ratio was calculated. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Some echocardiographic recordings at some time point may be of insufficient quality or missing, and the number of observations may not always correspond to the total number of participants at all time points. |
| Secondary | Blood Pressure | Baseline to 48 weeks | Difference in Diastolic Blood Pressure. Repeated measures multivariable analysis of variance (MANOVA) at time points 0, 12, 24, and 48 weeks |
| Secondary | Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System | Baseline to 48 weeks | Venous plasma concentrations of angiotensin II were measured in order to study the possible associations between the activity of the renin-angiotensin-aldosteone system and changes in left ventricular mass. Further analyses of other components of the renin-angiotensin-aldosterone system and of other hormonal system (e.g. the sympathetic nervous system) have also been performed and published. Repeated measures MANOVA at time points 0, 12, 24, and 48 weeks. Data were log-transformed to avoid skewness before statistical evaluation. However, tabular data are given as mean values with 95% confidence to improve readability. |
| Secondary | Effects on Carotid Artery Wall Thickness | Baseline to 48 weeks | Changes in common carotid artery intima-media thickness, assessed by ultrasonography. |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| SECONDARY | Number of Participants With Serious Adverse Events | Treatment period was baseline to 48 weeks | Participants | NUMBER | |
| PRIMARY | Changes in Left Ventricular Mass Index | Baseline and 48 weeks | Data on echocardiography is not always available at all time points and for all participants. This is reflected by the number of observations, which sometimes are less than the number of participants. | g/m^2 | MEAN |
| SECONDARY | Left Ventricular Diastolic Function Assessed by the E/A Ratio | Baseline to 48 weeks | ratio | MEAN | |
| SECONDARY | Blood Pressure | Baseline to 48 weeks | mm Hg | MEAN | |
| SECONDARY | Changes of Venous Plasma Angiotensin II as a Marker of the Renin-Angiotensin-Aldosterone System | Baseline to 48 weeks | pmol/L | MEAN | |
| SECONDARY | Effects on Carotid Artery Wall Thickness | Baseline to 48 weeks | mm | MEAN |
Source ClinicalTrials.gov
Results by group24
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Serious Adverse Events | Atenolol | 5 | Participants | ||
| Number of Participants With Serious Adverse Events | Irbesartan | 5 | Participants | ||
| Changes in Left Ventricular Mass Index | Atenolol | 12 weeks | -1 | 95% Confidence Interval -6 to 4 | g/m^2 |
| Changes in Left Ventricular Mass Index | Irbesartan | 12 weeks | -9 | 95% Confidence Interval -15 to -6 | g/m^2 |
| Changes in Left Ventricular Mass Index | Atenolol | 24 weeks | -6 | 95% Confidence Interval -12 to 0 | g/m^2 |
| Changes in Left Ventricular Mass Index | Irbesartan | 24 weeks | -14 | 95% Confidence Interval -22 to -6 | g/m^2 |
| Changes in Left Ventricular Mass Index | Atenolol | 48 weeks | -14 | 95% Confidence Interval -20 to 9 | g/m^2 |
| Changes in Left Ventricular Mass Index | Irbesartan | 48 weeks | -26 | 95% Confidence Interval -34 to -18 | g/m^2 |
| Left Ventricular Diastolic Function Assessed by the E/A Ratio | Atenolol | Week 12 | 0.18 | Standard Deviation 0.23 | ratio |
| Left Ventricular Diastolic Function Assessed by the E/A Ratio | Irbesartan | Week 12 | 0.10 | Standard Deviation 0.22 | ratio |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Irbesartan | 56 | |
| Overall Study | STARTED | Atenolol | 58 | |
| Overall Study | COMPLETED | Irbesartan | 47 | |
| Overall Study | COMPLETED | Atenolol | 53 | |
| Overall Study | NOT COMPLETED | Irbesartan | 9 | |
| Overall Study | NOT COMPLETED | Atenolol | 5 |
Source ClinicalTrials.gov
Adverse events4
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 | inadequate blood pressure reduction | Cardiac disorders | Irbesratan | 2 | 56 | 2 |
| serious | inadequate blood pressure reduction | Cardiac disorders | Atenolol | 0 | 58 | 0 |
| serious | events were not documented specifically in the records available | Social circumstances | Irbesratan | 3 | 56 | 3 |
| serious | events were not documented specifically in the records available | Social circumstances | Atenolol | 5 | 58 | 5 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Irbesratan | ||
| Total, all-cause mortality | Atenolol | ||
| Total, other adverse events | Irbesratan | 0 | 56 |
| Total, other adverse events | Atenolol | 0 | 58 |
| Total, serious adverse events | Irbesratan | 5 | 56 |
| Total, serious adverse events | Atenolol | 5 | 58 |
Source ClinicalTrials.gov
Papers14
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 |
|---|---|
| Atenolol vs Irbesartan: Number of Participants With Serious Adverse Events | Trial comparisons |
| Irbesratan vs Atenolol: 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/NCT00389168
GET https://conductscience.org/api/trials/v1/NCT00389168/results?page=2