Trial · NCT00923156
Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure
NCT00923156, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2012-03-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure. Trials, record NCT00923156. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00923156
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Aliskiren, Ramipril, and the Combination on Levels of Angiotensin II in Patients With Decompensated Systolic Heart Failure
- NCT number
- NCT00923156
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 123 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Heart Failure
- Interventions
- aliskiren, ramipril, Placebo to aliskiren, Placebo to ramipril
- First posted
- 2009-06-18
- Last updated
- 2012-07-26
- Other registries' IDs
- eudract:2008-001035-35
- Results first posted
- 2012-03-05
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Venous Angiotensin II Levels After 12 Weeks of Treatment | Baseline. 12 Weeks (Day 84, period 2) | Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric mean ratio to baseline at Week 12 for Venous angiotensin II levels was calculated in patients with decompensated systolic heart failure (SHF) and left ventricular ejection fraction ≤40% at 0 hour pre-dose, 3 hours and 24 hours post-dose. |
| Secondary | Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment | Baseline, 12 weeks (84 days, period 2) | Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at 12 weeks for PRC was calculated at 0 hour pre-dose. |
| Secondary | Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment | Baseline,12 weeks (84 days, Period 2) | Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for tPRA was calculated at 0 hour pre-dose, 3 hour and 24 hour post-dose. |
| Secondary | Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment | Baseline, 12 weeks (Day 84 period 2) | Peripheral venous blood was collected after 30 minutes of rest in the sitting position for analysis of biomarkers. Geometric Mean Ratio to baseline at Week 12 for BNP was calculated at 0 hours pre-dose. |
| Secondary | Biomarker Urinary Aldosterone After 12 Weeks of Treatment | Baseline,12 weeks (Day 84 period 2) | 24 hour urine collections were performed. Geometric Mean Ratio to baseline at Week 12 for Urinary aldosterone was calculated 24 hours post-dose. |
| Secondary | Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration | 12 weeks | Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. |
| Secondary | Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration | 12 weeks | Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. |
| Secondary | Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau) | 12 weeks | Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. |
| Secondary | Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) | 12 weeks | Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. |
| Secondary | Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) | 12 weeks | Blood samples (2 mL) for the determination of aliskiren concentration in plasma were collected using an indwelling cannula inserted in a forearm vein. Samples were collected at week 12 (day 84): pre-dose, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 10 and 24 hours post-dose. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes11
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Venous Angiotensin II Levels After 12 Weeks of Treatment | Baseline. 12 Weeks (Day 84, period 2) | Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment | Baseline, 12 weeks (84 days, period 2) | Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Biomarker Trapping Plasma Renin Activity (tPRA) After 12 Weeks of Treatment | Baseline,12 weeks (84 days, Period 2) | Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. In each category n indicates patients with observations at that time point. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Biomarker B-type Natriuretic Peptide (BNP) After 12 Weeks of Treatment | Baseline, 12 weeks (Day 84 period 2) | Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Biomarker Urinary Aldosterone After 12 Weeks of Treatment | Baseline,12 weeks (Day 84 period 2) | Pharmacodynamic (PD) Analysis Set: Subjects with any available PD data and no major protocol deviations with impact on PD data. Only patients with a value at both baseline and post-dose are included. | ratio | GEOMETRIC_MEAN |
| SECONDARY | Pharmacokinetic of Aliskiren: Time to Reach the Maximum Concentration (Tmax) After Drug Administration | 12 weeks | All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis. | Hour | MEDIAN |
| SECONDARY | Pharmacokinetic of Aliskiren: The Observed Maximum Plasma Concentration (Cmax) Following Drug Administration | 12 weeks | All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis. | ng/mL | MEAN |
| SECONDARY | Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the End of the Dosing Interval Tau(AUCtau) | 12 weeks | All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis. | hr*ng/mL | MEAN |
| SECONDARY | Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to the Time of the Last Quantifiable Concentration (AUClast) | 12 weeks | All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis. | hr*ng/mL | MEAN |
| SECONDARY | Pharmacokinetic of Aliskiren: The Area Under the Plasma Concentration-time Curve From Time Zero to Infinity (AUCinf) | 12 weeks | All subjects with evaluable PK parameter data and no major protocol deviations with impact on PK data were included in the PK data analysis. | hr*ng/mL | MEAN |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 outcomesResults by group33
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Aliskiren | 0 Hour pre-dose (n=40, 38, 37) | 0.91 | 95% Confidence Interval 0.52 to 1.59 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Ramipril | 0 Hour pre-dose (n=40, 38, 37) | 1.08 | 95% Confidence Interval 0.64 to 1.81 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Aliskiren Plus Ramipril | 0 Hour pre-dose (n=40, 38, 37) | 0.66 | 95% Confidence Interval 0.37 to 1.18 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Aliskiren | 3 hour post-dose (n=40, 38, 38) | 0.38 | 95% Confidence Interval 0.23 to 0.62 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Ramipril | 3 hour post-dose (n=40, 38, 38) | 0.44 | 95% Confidence Interval 0.24 to 0.78 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Aliskiren Plus Ramipril | 3 hour post-dose (n=40, 38, 38) | 0.38 | 95% Confidence Interval 0.22 to 0.66 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Aliskiren | 24 hour post-dose (n=40, 38, 38) | 0.79 | 95% Confidence Interval 0.44 to 1.41 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Ramipril | 24 hour post-dose (n=40, 38, 38) | 0.97 | 95% Confidence Interval 0.59 to 1.60 | ratio |
| Venous Angiotensin II Levels After 12 Weeks of Treatment | Aliskiren Plus Ramipril | 24 hour post-dose (n=40, 38, 38) | 0.64 | 95% Confidence Interval 0.34 to 1.24 | ratio |
| Biomarker Plasma Renin Concentration (PRC)After 12 Weeks of Treatment | Aliskiren | 2.48 | 95% Confidence Interval 1.67 to 3.66 | ratio |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aliskiren | 40 | |
| Overall Study | STARTED | Ramipril | 42 | |
| Overall Study | STARTED | Aliskiren Plus Ramipril | 41 | |
| Overall Study | COMPLETED | Aliskiren | 40 | |
| Overall Study | COMPLETED | Ramipril | 38 | |
| Overall Study | COMPLETED | Aliskiren Plus Ramipril | 38 | |
| Overall Study | NOT COMPLETED | Aliskiren | 0 | |
| Overall Study | NOT COMPLETED | Ramipril | 4 | |
| Overall Study | NOT COMPLETED | Aliskiren Plus Ramipril | 3 |
Source ClinicalTrials.gov
Adverse events36
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 | Tachycardia | Cardiac disorders | Ramipril | 0 | 42 | |
| other | Tachycardia | Cardiac disorders | Aliskiren | 1 | 40 | |
| other | Tachycardia | Cardiac disorders | Ramipril + Aliskiren | 5 | 41 | |
| other | Nasopharyngitis | Infections and infestations | Ramipril | 2 | 42 | |
| other | Nasopharyngitis | Infections and infestations | Aliskiren | 0 | 40 | |
| other | Nasopharyngitis | Infections and infestations | Ramipril + Aliskiren | 3 | 41 | |
| other | Electrocardiogram QT prolonged | Investigations | Ramipril | 4 | 42 | |
| other | Electrocardiogram QT prolonged | Investigations | Aliskiren | 2 | 40 | |
| other | Electrocardiogram QT prolonged | Investigations | Ramipril + Aliskiren | 1 | 41 | |
| serious | Acute myocardial infarction | Cardiac disorders | Ramipril | 1 | 42 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ramipril | ||
| Total, all-cause mortality | Aliskiren | ||
| Total, all-cause mortality | Ramipril + Aliskiren | ||
| Total, other adverse events | Ramipril | 6 | 42 |
| Total, other adverse events | Aliskiren | 3 | 40 |
| Total, other adverse events | Ramipril + Aliskiren | 7 | 41 |
| Total, serious adverse events | Ramipril | 7 | 42 |
| Total, serious adverse events | Aliskiren | 2 | 40 |
| Total, serious adverse events | Ramipril + Aliskiren | 3 | 41 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 33089502 | DERIVED |
Source PubMed
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.
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