HypertensionPhase 2NCT00498433

Effects of Aliskiren and Amlodipine on the Renin-Angiotensin System (RAS) and Lipid/Carbohydrate Metabolism in Obese Patients With Hypertension

A Phase 2 study testing Aliskiren and Amlodipine in people with Hypertension and Abdominal Obesity, run by Novartis at 2 sites in Germany.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

Part 1 determined: aliskiren, amlodipine and angiotensin II concentrations in interstitial fluid of fat and skeletal muscle; aliskiren and angiotensin II concentrations, and renin activity and concentration in fat and skeletal muscle tissues (biopsies); aliskiren, amlodipine and angiotensin II concentrations, and… Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Hypertension, Abdominal Obesity
What is being tested?: Aliskiren and Amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 46 participants
Where: 2 sitesGermany
Study dates: Jun 2007to Mar 2012
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

PART 1:
Male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
For patients with a history of treated hypertension, mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) had to be ≥ 120/80 mmHg and ≤ 160/100 mm Hg. For patients with newly diagnosed, untreated hypertension msSBP/msDBP had to be ≥ 135/85 mmHg and ≤ 160/100 mm Hg
Pulse rate 40 - 90 bpm
PART 2:
Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)

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Systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. Vital signs had to be within the following ranges:
Patients with history of treated hypertension: msSBP/msDBP ≥ 135/85 mmHg and < 160/100 mmHg at baseline
Patients with newly diagnosed, untreated hypertension: msSBP/msDBP ≥ 135/85 mmHg and < 160/100 mmHg at screening and baseline.

Who cannot join

PART 1
Hypertension Grade 2 (msSBP ≥ 160 mmHg) or Grade 3 (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) WHO classification
Current treatment with three or more antihypertensive drugs.
PART 2
Hypertension Grade 2 (msSBP ≥ 160 and/or msDBP ≥ 100 mmHg).
Current treatment with three or more antihypertensive drugs.
Other protocol-defined inclusion/exclusion criteria applied

Trial locations and contacts

2 sites in 1 country.

Germany2 sites

Novartis Investigative Site
Buch, 13125
Novartis Investigative Site
Hanover, 30159

Other trials in Germany

About this study

Official title: Part 1: An Open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin- Angiotensin System (RAS) in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity. Part 2: A Randomized, Double Blind, 12-weeks Parallel Group Study to Compare Effects of Aliskiren 300 mg and Amlodipine 5 mg on the RAS and Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity

Part 2 investigated the potential for aliskiren to modulate renin-angiotensin-aldosterone system (RAAS) activity, and lipid/carbohydrate metabolism in adipose and skeletal muscle tissue in obese patients with hypertension in comparison to amlodipine.

Conditions: Hypertension, Abdominal Obesity
Being tested: Aliskiren, Amlodipine, Placebo of Aliskiren, Placebo of amlodipine
Keywords: Aliskiren, Renin-Angiotensin System (RAS), Hypertension, Abdominal obesity
Medical subject headings: Hypertension, Obesity, Abdominal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AliskirenDrug
Also called SPP100
300 mg tablet once daily
AmlodipineDrug
5 mg capsule once daily
Placebo of AliskirenDrug
Matching placebo of aliskiren 300 mg tablet
Placebo of amlodipineDrug
Matching placebo of amlodipine 5 mg capsule

Study groups in NCT00498433
Study group	Role	What they receive
Aliskiren	Experimental	Part 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase (period 1) consisting of treatment with one tablet of placebo to aliskiren once daily (o.d.). This was followed by a 4 week treatment phase (period 2) consisting of treatment with 300 mg aliskiren o.d.. Part 2: Eligible randomized patients in this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks. Receives: Drug: Aliskiren; Drug: Placebo of Aliskiren; Drug: Placebo of amlodipine
Amlodipine	Active comparator	Part 1: After aliskiren treatment (period 2), each patient was entered into a second washout period (4 weeks) during which blood pressure was required to be ≤ 140/90 mmHg. If blood pressure exceeded 140/90 mmHg on two consecutive days (home monitoring) and was confirmed at the study center, the patient was entered into the amlodipine treatment period (period 3). In period 3, all patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks. Part 2: Eligible patients randomized to part 2 received amlodipine 5 mg o.d. and aliskiren placebo for 12 weeks Receives: Drug: Amlodipine; Drug: Placebo of Aliskiren

What is being measured

The primary outcome is the main question the study is designed to answer.

Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period
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).
Measured: Day 42
Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period
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).
Measured: Day 98
Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period
Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.
Measured: Day 42
Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period
Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.
Measured: Day 98
Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period
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).
Measured: Day 42
Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period
Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.
Measured: Day 42
Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period
Measured: Day 42
Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period
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).
Measured: Day 42
Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period
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).
Measured: Day 98
Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period
Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.
Measured: Day 42
Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period
Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.
Measured: Day 98
Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period
Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).
Measured: Day 42
Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period
Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).
Measured: Day 98
Part 1: Renin Activity From Plasma During Aliskiren Treatment Period
Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.
Measured: Day 42
Part 1: Renin Activity From Plasma During Amlodipine Treatment Period
Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.
Measured: Day 98
Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period
Interstitial fluid was obtained from subcutaneous adipose and skeletal muscle tissues by microdialysis using the zero-flow method to determine Ang II concentration.
Measured: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period
Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).
Measured: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period
Measured: Day 98
Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period
Measured: Day 98

Secondary outcomes (6)

Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)
Measured: Day 14 and Day 98
Part 2: Change From Baseline in Official Blood Pressure
Measured: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid
Measured: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)
Measured: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)
Measured: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death
Measured: 98 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jun 2007Mar 2012

First posted10 Jul 2007 (estimated)
Study startJun 2007
Primary completionMar 2012
Study completionMar 2012

Why it stopped: Early termination resulted from interim analysis of the ALTITUDE trial

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertensionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 46 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00498433
Sponsor's protocol ID: CSPP100A2238
Status last verified: Sep 2014
First submitted: 8 Jul 2007
Last updated: 10 Sep 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Part 1: An Open Label Pilot Study to Determine Interstitial and Tissue Concentrations of Aliskiren and Effects on the Renin- Angiotensin System (RAS) in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity. Part 2: A Randomized, Double Blind, 12-weeks Parallel Group Study to Compare Effects of Aliskiren 300 mg and Amlodipine 5 mg on the RAS and Lipid/Carbohydrate Metabolism in Fat and Skeletal Muscle of Hypertensive Patients With Abdominal Obesity
ClinicalTrials.gov ID: NCT00498433
Acronym / sponsor ID: CSPP100A2238
Conditions: Hypertension, Abdominal Obesity
Keywords: Aliskiren, Renin-Angiotensin System (RAS), Hypertension, Abdominal obesity
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Early termination resulted from interim analysis of the ALTITUDE trial
Enrolment: 46 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jun 2007
Primary completion: Mar 2012 (actual)
Study completion: Mar 2012 (actual)
First posted: 10 Jul 2007 (estimated)
Results: Posted 24 Oct 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Aliskiren	Experimental	Drug: Aliskiren, Drug: Placebo of Aliskiren, Drug: Placebo of amlodipinePart 1: After a 1-2 weeks initial washout period, all eligible patients underwent a two week placebo run-in phase (period 1) consisting of treatment with one tablet of placebo to aliskiren once daily (o.d.). This was followed by a 4 week treatment phase (period 2) consisting of treatment with 300 mg aliskiren o.d.. Part 2: Eligible randomized patients in this arm received aliskiren 300 mg tablet o.d. and amlodipine placebo capsule o.d. for 12 weeks.
Amlodipine	Active comparator	Drug: Amlodipine, Drug: Placebo of AliskirenPart 1: After aliskiren treatment (period 2), each patient was entered into a second washout period (4 weeks) during which blood pressure was required to be ≤ 140/90 mmHg. If blood pressure exceeded 140/90 mmHg on two consecutive days (home monitoring) and was confirmed at the study center, the patient was entered into the amlodipine treatment period (period 3). In period 3, all patients received 5 mg amlodipine o.d.. The length of the amlodipine period varied from 4 to 7 weeks. Part 2: Eligible patients randomized to part 2 received amlodipine 5 mg o.d. and aliskiren placebo for 12 weeks

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male and female patients 20 to 65 years of age with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
For patients with a history of treated hypertension, mean sitting systolic blood pressure (msSBP)/ mean sitting diastolic blood pressure (msDBP) had to be ≥ 120/80 mmHg and ≤ 160/100 mm Hg. For patients with newly diagnosed, untreated hypertension msSBP/msDBP had to be ≥ 135/85 mmHg and ≤ 160/100 mm Hg
Pulse rate 40 - 90 bpm
Male and female patients 18 to 65 years of age , with a diagnosis of hypertension and with abdominal obesity (waist circumference ≥ 102 cm in men and ≥ 88 cm in women)
Systolic and diastolic blood pressure and pulse rate were assessed after the patient had rested for at least five (5) minutes. Vital signs had to be within the following ranges:

Key exclusion criteria (7 listed)

PART 1
Hypertension Grade 2 (msSBP ≥ 160 mmHg) or Grade 3 (msDBP ≥ 110 mmHg and/or msSBP ≥ 180 mmHg) WHO classification
Current treatment with three or more antihypertensive drugs.
PART 2
Hypertension Grade 2 (msSBP ≥ 160 and/or msDBP ≥ 100 mmHg).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AliskirenAlso: SPP100300 mg tablet once daily	Drug	Aliskiren
Amlodipine5 mg capsule once daily	Drug	Amlodipine
Placebo of AliskirenMatching placebo of aliskiren 300 mg tablet	Drug	Aliskiren, Amlodipine
Placebo of amlodipineMatching placebo of amlodipine 5 mg capsule	Drug	Aliskiren

Primary outcome

Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period
Time frame: 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).
Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period
Time frame: 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).
Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period
Time frame: 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.
Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period
Time frame: 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.
Part 1: Aliskiren Concentrations From Tissue at the End of Aliskiren Treatment Period
Time frame: 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).
Part 1: Angiotensin II Levels From Tissue During Aliskiren Treatment Period
Time frame: Day 42
Biopsies were taken from abdominal adipose and skeletal muscle tissue to determine Ang II concentration.
Part 1: Renin Activity and Concentrations From Adipose and Skeletal Tissues During Aliskiren Treatment Period
Time frame: Day 42
Part 1: Aliskiren Concentrations From Plasma at the End of Aliskiren Treatment Period
Time frame: 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).
Part 1: Amlodipine Concentrations From Plasma at the End of Amlodipine Treatment Period
Time frame: 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).
Part 1: Angiotensin II Levels in Plasma During Aliskiren Treatment Period
Time frame: 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.
Part 1: Angiotensin II Levels in Plasma During Amlodipine Treatment Period
Time frame: 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.
Part 1: Renin Concentrations From Plasma During Aliskiren Treatment Period
Time frame: Day 42
Renin concentrations from plasma were measured as: plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).
Part 1: Renin Concentrations From Plasma During Amlodipine Treatment Period
Time frame: Day 98
Renin concentrations from plasma were measured as plasma renin concentration (PRC), prorenin concentration and total renin concentration (renin + prorenin concentration).
Part 1: Renin Activity From Plasma During Aliskiren Treatment Period
Time frame: Day 42
Plasma Renin activity (PRC) was measured by a trapping PRA (tPRA) assay.
Part 1: Renin Activity From Plasma During Amlodipine Treatment Period
Time frame: Day 98
Plasma renin activity (PRC) was measured by a trapping PRA (tPRA) assay.
Part 2: Change From Baseline in Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Double Blind Treatment Period
Time frame: Placebo Baseline (Day 14), Active Treatment (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.
Part 2: Change From Baseline in Plasma Angiotensin II Levels During Double Blind Treatment Period
Time frame: Placebo Baseline (Day 14), Active Treatment (Day 98)
Plasma Ang II was measured prior to and 1 hour after the Insulin modified-frequently sampled intravenous glucose tolerance test (IM-FSIGT) during placebo treatment (Days 14) and active treatment(Day 98).
Part 2: Plasma Renin Activity (PRA) Concentration During Double Blind Treatment Period
Time frame: Day 98
Part 2: Plasma Renin Concentration (PRC) Levels During Double Blind Treatment Period
Time frame: Day 98

6 secondary outcomes

Part 2: Microdialysis Metabolic Analytes in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)
Time frame: Day 14 and Day 98
Part 2: Change From Baseline in Official Blood Pressure
Time frame: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Renin Activity and Concentration of Aliskiren and Amlodipine in Fat and Skeletal Muscle Interstitial Fluid
Time frame: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Change From Baseline in Peripheral Insulin Sensitivity in Response to Insulin Modified Frequently Sampled Intravenous Glucose Test [IM-FSIGT]for Each Tissue (Adipose or Skeletal Muscle)
Time frame: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Change From Baseline in Mitochondrial Mass in Subcutaneous Fat and Skeletal Muscle (Tissue Biopsies)
Time frame: Placebo Baseline (Day 14), Active Treatment (Day 98)
Part 2: Number of Participants With Reported Any Adverse Events, Serious Adverse Events and Death
Time frame: 98 days

Results and safety

Results posted to the registry on 24 Oct 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	10	10
Aliskiren	0	0
Amlodipine	0	0

Primary outcome: Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period

Time frame: Day 42. Mean (Standard Deviation). Unit: ng/mL

Measure	Part 1: Placebo/Aliskiren/Amlodipine n = 10
Adipose tissue	2.38 (2.11)
Skeletal muscle	7.05 (4.24)

Population analysed: 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.

Primary outcome: Part 1: Amlodipine Concentrations From Interstitial Fluid (Microdialysis) at the End of Amlodipine Treatment Period

Time frame: Day 98

Population analysed: Zero flow concentrations from microdialysates could not be derived by linear regression because of missing data due to inadequate sample volumes.

Primary outcome: Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Aliskiren Treatment Period

Time frame: Day 42

Population analysed: Due to technical limitations, zero flow concentrations could not be derived for Ang II.

Primary outcome: Part 1: Angiotensin II Levels in Interstitial Fluid of Fat and Skeletal Muscle (Microdialysis) During Amlodipine Treatment Period

Time frame: Day 98

Population analysed: Due to technical limitations, zero flow concentrations could not be derived for Ang II.

6 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Part 1: Aliskiren	1 of 10 (10%)	6 of 10 (60%)	Not reported
Part 1: Amlodipine	0 of 10 (0%)	3 of 10 (30%)	Not reported
Part 2: Placebo run-in Period	1 of 36 (2.8%)	1 of 36 (2.8%)	Not reported
Part 2: Aliskiren	0 of 8 (0%)	2 of 8 (25%)	Not reported
Part 2: Amlodipine	0 of 8 (0%)	3 of 8 (37.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Novartis principal investigator

Investigative site

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Aliskiren and Amlodipine in people with Hypertension and Abdominal Obesity, run by Novartis at 2 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Oct 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Part 1: Aliskiren Concentrations From Interstitial Fluid (Microdialysis)at the End of Aliskiren Treatment Period (time frame: Day 42). The study lists 19 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00498433.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.