Trial · NCT00417170
Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome
NCT00417170, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2011-08-11
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome. Trials, record NCT00417170. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00417170
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Comparison of Aliskiren and Amlodipine on Insulin Resistance and Endothelial Dysfunction in Patients With Hypertension and Metabolic Syndrome
- NCT number
- NCT00417170
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 48 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- High Blood Pressure, Metabolic Syndrome, Insulin Resistance, Endothelial Dysfunction
- Interventions
- Aliskiren, Amlodipine, Placebo Aliskiren, Placebo Amlodipine
- First posted
- 2006-12-29
- Last updated
- 2011-09-26
- Results first posted
- 2011-08-11
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment | At baseline and after 12 weeks of treatment | MBF is measured by Positron Emission Tomography (PET) first at rest, then 45 minutes later, during cold pressor testing (CPT). The patient is placed in the PET scanner and injected with N-13 ammonia as a tracer. PET images are taken to assess myocardial blood flow at rest. After 40 minutes, the patient immerses one hand in ice water and PET images are taken to assess myocardial blood flow at sympathetic activation. Change from baseline data is analyzed by an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor. |
| Secondary | Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment. | At baseline and after 12 weeks of treatment | Insulin sensitivity is measured by the hyperglycemic euglycemic clamp procedure where a supine patient has 2 IV lines inserted for sampling blood. Regular human insulin (60mU/m\^2 surface area/min) is infused for 120 minutes. Dextrose (20% w/v) is infused to maintain glycemia at \< 100 mg/dL and is adjusted based on plasma glucose levels obtained every 5 minutes. Blood for glucose and insulin is taken at specified time intervals. Change from baseline data is analyzed by analysis of variance model including treatment and week as fixed factors, and subject (nested in treatment) as a random factor. |
| Secondary | Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | At baseline and after 12 weeks of treatment | Insulin Concentration is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor. |
| Secondary | Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment | Baseline and after 12 weeks of treatment | C-peptide level is determined by the Oral Glucose Tolerance Test (OGTT) which begins after a 10 hour overnight fast. Blood samples are taken at baseline and after an oral 75 gram dose of glucose. Additional samples of blood are taken to measure glucose and insulin levels at 30, 60, 120 and 180 minutes post glucose intake. Changes from pre-glucose intake values are analyzed by an analysis of variance (ANOVA) model including treatment, visit and post-dose time points ( 30, 60, 120 and 180 minutes) as fixed factors and subject (nested in treatment) as a random factor. |
| Secondary | Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment | At baseline and after 12 weeks of treatment | Arterial Compliance is determined by Pulse Wave Analysis measured by a detector placed at the carotid artery while taking ECG and tonometry at the same time. Procedure is repeated for the femoral artery. Pulse Wave data are calculated by dividing distance between 2 arteries by the difference between the rise delay of the distal pulse wave and the R wave of the QRS complex and the rise delay of the proximal pulse wave to the QRS complex. Data analysis used an analysis of variance (ANOVA) model including treatment and week as fixed factors and subject (nested in treatment) as a random factor. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment | At baseline and after 12 weeks of treatment | The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis. | mL/g/min | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment. | At baseline and after 12 weeks of treatment | The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis. | mg/kg/min | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | At baseline and after 12 weeks of treatment | The Pharmacodynamic (PD) analysis set included all participants with available PD data and no major protocol deviation with impact on PD data. During different time points, participants with observations at that time point were included in the analysis. | mU/L | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in Inflammatory Marker ( C-peptide) as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment [Time Frame: At Baseline and After 12 Weeks of Treatment | Baseline and after 12 weeks of treatment | The PD analysis set included all subjects with available PD data and no major protocol deviations with impact on PD data. During different time points, participants with observations at that time point were included in the analysis. | ng/mL | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change in Arterial Compliance as Measured by Pulse Wave Analysis From Baseline and After 12 Weeks of Treatment | At baseline and after 12 weeks of treatment | The Pharmacodynamic (PD) analysis set includes all participants with available PD data and no major protocol deviation with impact on PD data. Participants with observations at both baseline and endpoint were included in the analysis. | mmHg | LEAST_SQUARES_MEAN |
Source ClinicalTrials.gov
Results by group28
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment | Aliskiren 300 mg | 0.06 | Standard Error 0.39 | mL/g/min | |
| Mean Change in Endothelial Function as Measured by Myocardial Blood Flow (MBF) From Baseline and After 12 Weeks of Treatment | Amlodipine 5 mg | 0.12 | Standard Error 0.39 | mL/g/min | |
| Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment. | Aliskiren 300 mg | 0.23 | Standard Error 0.379 | mg/kg/min | |
| Mean Change in Insulin Sensitivity as Measured by Glucose Infusion Rate (Last 30 Minutes) From Baseline and After 12 Weeks of Treatment. | Amlodipine 5 mg | 0.55 | Standard Error 0.371 | mg/kg/min | |
| Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | Aliskiren 300 mg | 0 minutes (n=21, 23) | 3.54 | Standard Error 14.666 | mU/L |
| Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | Amlodipine 5 mg | 0 minutes (n=21, 23) | -3.08 | Standard Error 14.014 | mU/L |
| Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | Aliskiren 300 mg | 30 minutes (n=17, 21) | 31.26 | Standard Error 15.748 | mU/L |
| Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | Amlodipine 5 mg | 30 minutes (n=17, 21) | -15.46 | Standard Error 14.436 | mU/L |
| Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | Aliskiren 300 mg | 60 minutes (n=19, 22) | 16.71 | Standard Error 15.169 | mU/L |
| Mean Change in Insulin Concentration as Measured During Oral Glucose Tolerance Test (OGTT) From Baseline and After 12 Weeks of Treatment | Amlodipine 5 mg | 60 minutes (n=19, 22) | -27.87 | Standard Error 14.231 | mU/L |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 results by groupParticipant flow8
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Aliskiren 300 mg | 23 | |
| Overall Study | STARTED | Amlodipine 5 mg | 25 | |
| Overall Study | Pharmacodynamics Population | Aliskiren 300 mg | 21 | |
| Overall Study | Pharmacodynamics Population | Amlodipine 5 mg | 23 | |
| Overall Study | COMPLETED | Aliskiren 300 mg | 21 | |
| Overall Study | COMPLETED | Amlodipine 5 mg | 22 | |
| Overall Study | NOT COMPLETED | Aliskiren 300 mg | 2 | |
| Overall Study | NOT COMPLETED | Amlodipine 5 mg | 3 |
Source ClinicalTrials.gov
Adverse events8
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 | OEDEMA PERIPHERAL | General disorders | Aliskiren 300mg | 0 | 23 | |
| other | OEDEMA PERIPHERAL | General disorders | Amlodipine 5mg | 2 | 25 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Aliskiren 300mg | 2 | 23 | |
| other | UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | Amlodipine 5mg | 1 | 25 | |
| other | GLUCOSE TOLERANCE INCREASED | Investigations | Aliskiren 300mg | 0 | 23 | |
| other | GLUCOSE TOLERANCE INCREASED | Investigations | Amlodipine 5mg | 2 | 25 | |
| other | MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | Aliskiren 300mg | 0 | 23 | |
| other | MUSCLE SPASMS | Musculoskeletal and connective tissue disorders | Amlodipine 5mg | 2 | 25 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Aliskiren 300mg | ||
| Total, all-cause mortality | Amlodipine 5mg | ||
| Total, other adverse events | Aliskiren 300mg | 2 | 23 |
| Total, other adverse events | Amlodipine 5mg | 6 | 25 |
| Total, serious adverse events | Aliskiren 300mg | 0 | 23 |
| Total, serious adverse events | Amlodipine 5mg | 0 | 25 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
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 |
|---|
| Aliskiren 300mg vs Amlodipine 5mg: 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/NCT00417170
GET https://conductscience.org/api/trials/v1/NCT00417170/results?page=2