Trial · NCT00498433
Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension
NCT00498433, Phase 2, Terminated, Novartis; results first posted 2013-10-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension. Trials, record NCT00498433. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00498433
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension
- NCT number
- NCT00498433
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 46 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Hypertension, Abdominal Obesity
- Interventions
- Aliskiren, Amlodipine, Placebo of Aliskiren, Placebo of amlodipine
- First posted
- 2007-07-10
- Last updated
- 2014-09-10
- Results first posted
- 2013-10-24
Source ClinicalTrials.gov
Registered outcomes25
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period | Day 42 | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentrations on the last day of the aliskiren treatment periods (Day 42). |
| Primary | Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period | Day 98 | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method. Interstitial fluid was collected for measurements of drug concentration on the last day of the amlodipine treatment periods (Day 98). |
| Primary | Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period | Day 42 | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. |
| Primary | Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period | Day 98 | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. |
| Primary | Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period | Day 42 | Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine aliskiren concentration. Tissue biopsy samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). |
| Primary | Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period | Day 42 | Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration. |
| Primary | Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period | Day 42 | |
| Primary | Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period | Day 42 | Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the aliskiren treatment periods (Day 42). |
| Primary | Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period | Day 98 | Plasma samples were obtained for measurement of aliskiren or amlodipine concentrations. All blood samples were taken by an indwelling cannula inserted in a forearm vein or direct venipuncture. The plasma samples for drug concentrations analyses were taken on the last day of the amlodipine treatment periods (Day 98). |
| Primary | Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period | Day 42 | Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 registered outcomesOutcomes25
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period | Day 42 | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics (PK)/ pharmacodynamics (PD) data were included in the data analysis. | ng/mL | MEAN |
| PRIMARY | Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period | Day 98 | Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes. | ||
| SECONDARY | Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle) | Day 14 and Day 98 | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | ||
| SECONDARY | Part 2: Change From Baseline in Official Blood Pressure | Placebo Baseline (Day 14), Active Treatment (Day 98) | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | ||
| SECONDARY | Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid | Placebo Baseline (Day 14), Active Treatment (Day 98) | Total 40 completed subjects needed to have a power of 80% in detecting a significant difference between treatment groups. Due to early termination, the study was limited by a small sample size; hence, the planned analysis was not done. | ||
| PRIMARY | Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period | Day 42 | Due to technical limitations, zero flow concentrations could not be derived for Ang II. | ||
| PRIMARY | Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period | Day 98 | Due to technical limitations, zero flow concentrations could not be derived for Ang II. | ||
| PRIMARY | Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period | Day 42 | All patients who received at least one dose of study drug and had at least one post-baseline assessment of pharmacokinetics data were included in the data analysis. | ng/g | MEAN |
| PRIMARY | Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period | Day 42 | More than 50% of the biopsy samples over all time points were either below lower limit of quantification (LLOQ) or not received. | ||
| PRIMARY | Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period | Day 42 | Renin activity and concentration from adipose tissue and skeletal muscles were all below lower limitation of quantification (LLOQ) at all time points. |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 outcomesResults by group25
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | Adipose tissue | 2.38 | Standard Deviation 2.11 | ng/mL |
| Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | Skeletal muscle | 7.05 | Standard Deviation 4.24 | ng/mL |
| Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | Adipose tissue (n=6) | 29.05 | Standard Deviation 16.71 | ng/g |
| Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | Skeletal muscle (n=9) | 107.32 | Standard Deviation 68.64 | ng/g |
| Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | 8.38 | Standard Deviation 4.41 | ng/mL | |
| Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | 7.78 | Standard Deviation 3.61 | ng/mL | |
| Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | 0.534 | 95% Confidence Interval 0.223 to 1.28 | fmol/mL | |
| Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | 2.20 | 95% Confidence Interval 0.88 to 5.51 | fmol/mL | |
| Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | Plasma Renin Concentration | 22.29 | 95% Confidence Interval 8.98 to 55.32 | pg/mL |
| Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period | Part 1: Placebo/Aliskiren/Amlodipine | Total Renin Concentration | 89.9 | 95% Confidence Interval 52.4 to 154.2 | pg/mL |
1 to 10 of 25Source ClinicalTrials.gov
See all 25 results by groupParticipant flow45
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part 1, Period 1:Placebo Run-in(2 Weeks) | STARTED | Placebo | 10 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | STARTED | Aliskiren | 0 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | STARTED | Amlodipine | 0 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | COMPLETED | Placebo | 10 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | COMPLETED | Aliskiren | 0 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | COMPLETED | Amlodipine | 0 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | NOT COMPLETED | Placebo | 0 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | NOT COMPLETED | Aliskiren | 0 | |
| Part 1, Period 1:Placebo Run-in(2 Weeks) | NOT COMPLETED | Amlodipine | 0 | |
| Part 1, Period 2: Aliskiren (4 Weeks) | STARTED | Placebo | 0 |
1 to 10 of 45Source ClinicalTrials.gov
See all 45 participant flowAdverse events90
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 | DIARRHOEA | Gastrointestinal disorders | Part 1: Aliskiren | 0 | 10 | |
| other | DIARRHOEA | Gastrointestinal disorders | Part 1: Amlodipine | 1 | 10 | |
| other | DIARRHOEA | Gastrointestinal disorders | Part 2: Placebo run-in Period | 0 | 36 | |
| other | DIARRHOEA | Gastrointestinal disorders | Part 2: Aliskiren | 0 | 8 | |
| other | DIARRHOEA | Gastrointestinal disorders | Part 2: Amlodipine | 1 | 8 | |
| other | DRY MOUTH | Gastrointestinal disorders | Part 1: Aliskiren | 0 | 10 | |
| other | DRY MOUTH | Gastrointestinal disorders | Part 1: Amlodipine | 0 | 10 | |
| other | DRY MOUTH | Gastrointestinal disorders | Part 2: Placebo run-in Period | 0 | 36 | |
| other | DRY MOUTH | Gastrointestinal disorders | Part 2: Aliskiren | 1 | 8 | |
| other | DRY MOUTH | Gastrointestinal disorders | Part 2: Amlodipine | 0 | 8 |
1 to 10 of 90Source ClinicalTrials.gov
See all 90 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part 1: Aliskiren | ||
| Total, all-cause mortality | Part 1: Amlodipine | ||
| Total, all-cause mortality | Part 2: Placebo run-in Period | ||
| Total, all-cause mortality | Part 2: Aliskiren | ||
| Total, all-cause mortality | Part 2: Amlodipine | ||
| Total, other adverse events | Part 1: Aliskiren | 6 | 10 |
| Total, other adverse events | Part 1: Amlodipine | 3 | 10 |
| Total, other adverse events | Part 2: Placebo run-in Period | 1 | 36 |
| Total, other adverse events | Part 2: Aliskiren | 2 | 8 |
| Total, other adverse events | Part 2: Amlodipine | 3 | 8 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers0
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 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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