Trial · NCT00927394
Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
NCT00927394, Phase 4, Completed, Novartis; results first posted 2012-10-31
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus. Trials, record NCT00927394. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00927394
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Aliskiren and Valsartan vs Valsartan Alone in Patients With Stage II Systolic Hypertension and Type II Diabetes Mellitus
- NCT number
- NCT00927394
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 1,143 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Hypertension
- Interventions
- Aliskiren, Valsartan, Placebo for Aliskiren, Placebo for Valsartan
- First posted
- 2009-06-25
- Last updated
- 2012-12-06
- Results first posted
- 2012-10-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8 | baseline, week 8 | The 24-hour ambulatory systolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly systolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MASBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline, week 8 | Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8 | baseline, week 8 | The 24-hour ambulatory diastolic blood pressure was evaluated at baseline (Week 0) and post-baseline visits. The mean hourly diastolic blood pressure was calculated at post-dosing hours 1-24 for each patient. The MADBP for each patient was calculated by averaging the patient's available hourly means for post-dosing hours 1-24. |
| Secondary | Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8 | baseline, week 8 | The 24-hour ambulatory pulse pressure was evaluated at baseline (Week 0) and post-baseline visits. |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline, week 8 | Sitting blood pressure was measured at trough (24 hours ± 3 hours post dose) and recorded at all study visits. At the first study visit, the arm in which the highest sitting diastolic blood pressure was found was the arm used for all subsequent readings throughout the study. At each study visit, after the patient had been sitting for five minutes, systolic and diastolic blood pressures were measured 3 times using the standard mercury sphygmomanometer. The repeat sitting measurements were made at 1-2 minute intervals and the mean of these 3 sitting blood pressure measurements was used as the average sitting office blood pressure for that visit. |
| Secondary | Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8 | baseline, week 8 | At each visit, the pulse rate was measured for 30 seconds just prior to the first sitting blood pressure measurement. |
| Secondary | Percentage of Patients Achieving Blood Pressure Control | 8 weeks | Blood pressure control was defined as MSSBP/MSDBP \<140/90 mmHg. Percentage of patients achieving of blood pressure control at the corresponding visit was reported |
| Secondary | Percentage of Responders | Baseline, Week 8 | Responders were defined as patients with MSSBP \<130 mmHg or a reduction from baseline in MSSBP of \>20 mmHg.Percentage of responders achieving a response at the corresponding visit was reported. |
| Secondary | Change From Baseline in Plasma Renin Activity (PRA) at Week 8 | Baseline, week 8 | |
| Secondary | Change From Baseline in Plasma Renin Concentration (PRC) at Week 8 | Baseline, week 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8 | baseline, week 8 | Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Baseline, week 8 | Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8 | baseline, week 8 | Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8 | baseline, week 8 | Full Analysis Set 2 (FAS 2) with ambulatory blood pressure monitoring (ABPM)- Consists of all patients in Cohort 2 to whom study treatments were assigned through randomization and who had both valid baseline and post-baseline ambulatory blood pressure monitoring (ABPM)assessments. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Baseline, week 8 | Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Pulse Pressure (MSPP) at Week 8 | baseline, week 8 | Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 data were included in this analysis. Last-observation-carried-forward (LOCF) approach was used. | mmHg | MEAN |
| SECONDARY | Percentage of Patients Achieving Blood Pressure Control | 8 weeks | Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Number of patients with data at each visit were analyzed. | Percentage of patients | NUMBER |
| SECONDARY | Percentage of Responders | Baseline, Week 8 | Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis. | Percentage of patients | NUMBER |
| SECONDARY | Change From Baseline in Plasma Renin Activity (PRA) at Week 8 | Baseline, week 8 | Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis. | ng/mL/hr | MEAN |
| SECONDARY | Change From Baseline in Plasma Renin Concentration (PRC) at Week 8 | Baseline, week 8 | Combined FAS included all randomized patients in Cohort 1 (FAS 1) and all randomized patients in Cohort 2 who had a valid baseline assessment of 24-hour ambulatory systolic blood pressure measurement (FAS 2). Patients with baseline and week 8 assessments were included in this analysis. | ng/L | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8 | Combination Therapy: Aliskiren + Valsartan | -15.3 | Standard Deviation 14.62 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory Systolic Blood Pressure (MASBP) at Week 8 | Monotherapy: Valsartan | -11.5 | Standard Deviation 14.75 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Combination Therapy: Aliskiren + Valsartan | -21.7 | Standard Deviation 18.70 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) | Monotherapy: Valsartan | -18.2 | Standard Deviation 18.06 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8 | Combination Therapy: Aliskiren + Valsartan | -9.2 | Standard Deviation 8.80 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (MADBP) at Week 8 | Monotherapy: Valsartan | -6.7 | Standard Deviation 8.82 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8 | Combination Therapy: Aliskiren + Valsartan | -6.1 | Standard Deviation 8.58 | mmHg | |
| Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure (MAPP) at Week 8 | Monotherapy: Valsartan | -4.7 | Standard Deviation 8.26 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Combination Therapy: Aliskiren + Valsartan | -11.0 | Standard Deviation 10.58 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) | Monotherapy: Valsartan | -8.3 | Standard Deviation 10.60 | mmHg |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow20
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Combination Therapy: Aliskiren + Valsartan | 575 | |
| Overall Study | STARTED | Monotherapy: Valsartan | 568 | |
| Overall Study | Cohort 1 (Randomized) | Combination Therapy: Aliskiren + Valsartan | 157 | |
| Overall Study | Cohort 1 (Randomized) | Monotherapy: Valsartan | 165 | |
| Overall Study | Cohort 2 (Randomized) | Combination Therapy: Aliskiren + Valsartan | 418 | |
| Overall Study | Cohort 2 (Randomized) | Monotherapy: Valsartan | 403 | |
| Overall Study | Combined Safety Set (Cohort 1 and 2) | Combination Therapy: Aliskiren + Valsartan | 574 | |
| Overall Study | Combined Safety Set (Cohort 1 and 2) | Monotherapy: Valsartan | 565 | |
| Overall Study | Cohort 1: Full Analysis Set 1 (FAS 1) | Combination Therapy: Aliskiren + Valsartan | 157 | |
| Overall Study | Cohort 1: Full Analysis Set 1 (FAS 1) | Monotherapy: Valsartan | 164 |
1 to 10 of 20Source ClinicalTrials.gov
See all 20 participant flowAdverse events42
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 | Headache | Nervous system disorders | Combination Therapy: Aliskiren + Valsartan | 34 | 574 | |
| other | Headache | Nervous system disorders | Monotherapy: Valsartan | 36 | 565 | |
| serious | Angina pectoris | Cardiac disorders | Combination Therapy: Aliskiren + Valsartan | 1 | 574 | |
| serious | Angina pectoris | Cardiac disorders | Monotherapy: Valsartan | 0 | 565 | |
| serious | Angina unstable | Cardiac disorders | Combination Therapy: Aliskiren + Valsartan | 1 | 574 | |
| serious | Angina unstable | Cardiac disorders | Monotherapy: Valsartan | 0 | 565 | |
| serious | Atrial fibrillation | Cardiac disorders | Combination Therapy: Aliskiren + Valsartan | 1 | 574 | |
| serious | Atrial fibrillation | Cardiac disorders | Monotherapy: Valsartan | 0 | 565 | |
| serious | Cardiac failure congestive | Cardiac disorders | Combination Therapy: Aliskiren + Valsartan | 1 | 574 | |
| serious | Cardiac failure congestive | Cardiac disorders | Monotherapy: Valsartan | 1 | 565 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Combination Therapy: Aliskiren + Valsartan | ||
| Total, all-cause mortality | Monotherapy: Valsartan | ||
| Total, other adverse events | Combination Therapy: Aliskiren + Valsartan | 34 | 574 |
| Total, other adverse events | Monotherapy: Valsartan | 36 | 565 |
| Total, serious adverse events | Combination Therapy: Aliskiren + Valsartan | 9 | 574 |
| Total, serious adverse events | Monotherapy: Valsartan | 9 | 565 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 23339726 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Combination Therapy: Aliskiren + Valsartan vs Monotherapy: Valsartan: serious adverse events |
Source 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/NCT00927394
GET https://conductscience.org/api/trials/v1/NCT00927394/results?page=2