HypertensionPhase 2NCT01080768

Assessment of Aliskiren/Amlodipine and Amlodipine on Ankle Foot Volume (AFV) in Patients With Hypertension

A Phase 2 study testing Aliskiren/amlodipine and Amlodipine in people with Hypertension and Ankle Edema, run by Novartis Pharmaceuticals at 9 sites in Netherlands.

Terminated

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

Official record

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Trial summary

The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Hypertension, Ankle Edema
What is being tested?: Aliskiren/amlodipine and Amlodipine
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 31 participants
Where: 9 sitesNetherlands
Study dates: Feb 2010to Nov 2010
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 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients (male or female) with hypertension aged between 18-75 yrs.
Patients not treated with amlodipine or no amlodipine in previous 1 year.
Post-menopausal females

Who cannot join

Patients unable to switch from prior hypertensive medication.
Severe hypertension.
Pregnant or nursing females.
Patients with Type 1 or Type 2 diabetes mellitus
History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay [ELISA] and Western blot) test result.
A positive Hepatitis B surface antigen (HBsAg) or Hepatitis C test result.
Other protocol-defined inclusion/exclusion criteria are applied

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

Netherlands9 sites

Novartis Investigative Site
Beek en Donk
Novartis Investigative Site
Bosch
Novartis Investigative Site
Hoogwoud
Novartis Investigative Site
Lichtenvoorde
Novartis Investigative Site
Lieshout
Novartis Investigative Site
Poortvliet
Novartis Investigative Site
The Hague
Novartis Investigative Site
Utrecht
Novartis Investigative Site
Wildervank

Other trials in Netherlands

About this study

Official title: A Double Blind, Randomized, Parallel Study to Assess the Effects of Aliskiren/Amlodipine and Amlodipine Monotherapy on Ankle Foot Volume (AFV) in Patients naïve to Trial Drugs With Mild to Moderate Hypertension

The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.

Conditions: Hypertension, Ankle Edema
Being tested: Aliskiren/amlodipine, Amlodipine, Placebo to Aliskiren/amlodipine, Placebo to Amlodipine
Keywords: Pedal edema, hypertension, aliskiren, amlodipine
Medical subject headings: Hypertension

What participants receive

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

Aliskiren/amlodipineDrug
Also called SPA100
Aliskiren/amlodipine 150/5 mg/day
AmlodipineDrug
Amlodipine 5 mg/day.
Placebo to Aliskiren/amlodipineDrug
Placebo to Aliskiren/amlodipine 150/10 mg/day
Placebo to AmlodipineDrug
Placebo to Amlodipine 5 mg/day

Study groups in NCT01080768
Study group	Role	What they receive
Aliskiren/amlodipine + Placebo to amlodipine	Experimental	During the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine. The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day. Receives: Drug: Aliskiren/amlodipine; Drug: Placebo to Amlodipine
Amlodipine + Placebo to aliskiren/amlodipine	Active comparator	During the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day. The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day. Receives: Drug: Amlodipine; Drug: Placebo to Aliskiren/amlodipine

What is being measured

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

Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.
Measured: Baseline, 4 weeks

Timeline

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

Feb 2010Nov 2010

First posted4 Mar 2010 (estimated)
Study startFeb 2010
Primary completionNov 2010
Study completionNov 2010

Why it stopped: Publication of data from a similar study made the current study redundant.

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.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01080768
Sponsor's protocol ID: CSPA100A2201
Other IDs: 2009-014359-63, 2009
Status last verified: Nov 2011
First submitted: 3 Mar 2010
Last updated: 26 Dec 2011
Results posted: Yes, on ClinicalTrials.gov

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 26 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Double Blind, Randomized, Parallel Study to Assess the Effects of Aliskiren/Amlodipine and Amlodipine Monotherapy on Ankle Foot Volume (AFV) in Patients naïve to Trial Drugs With Mild to Moderate Hypertension
ClinicalTrials.gov ID: NCT01080768
Acronym / sponsor ID: CSPA100A2201
Conditions: Hypertension, Ankle Edema
Keywords: Pedal edema, hypertension, aliskiren, amlodipine
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Publication of data from a similar study made the current study redundant.
Enrolment: 31 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 4 Mar 2010 (estimated)
Results: Posted 26 Dec 2011

Clinical summary

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

The purpose of the present study was to evaluate the addition of aliskiren, to amlodipine can attenuate ankle edema formation in hypertensive patients.

Study design

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

Arm	Type	Receives
Aliskiren/amlodipine + Placebo to amlodipine	Experimental	Drug: Aliskiren/amlodipine, Drug: Placebo to AmlodipineDuring the first week of active treatment, patients were instructed to take one tablet of aliskiren/amlodipine 150/5 mg and one capsule of placebo to amlodipine daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 2 tablets of aliskiren/amlodipine 150/5 mg/day and 1 capsule of placebo to amlodipine. The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.
Amlodipine + Placebo to aliskiren/amlodipine	Active comparator	Drug: Amlodipine, Drug: Placebo to Aliskiren/amlodipineDuring the first week of active treatment, patients were instructed to take one capsule of amlodipine 5 mg and one tablet of placebo to aliskiren/amlodipine 150/5 mg daily. For the 2nd to 4th week of active treatment, the patients were up-titrated to take 1 capsule of amlodipine 10 mg/day and 2 tablets of placebo to aliskiren/amlodipine 150/5 mg/day. The patients were instructed to administer daily dose between 8:00 and 10:00 am preferably at the same time of the day.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Patients (male or female) with hypertension aged between 18-75 yrs.
Patients not treated with amlodipine or no amlodipine in previous 1 year.
Post-menopausal females

Key exclusion criteria (7 listed)

Patients unable to switch from prior hypertensive medication.
Severe hypertension.
Pregnant or nursing females.
Patients with Type 1 or Type 2 diabetes mellitus
History of immunodeficiency diseases, including a positive Human immunodeficiency virus (HIV) (Enzyme-linked immunosorbent assay [ELISA] and Western blot) test result.

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
Aliskiren/amlodipineAlso: SPA100Aliskiren/amlodipine 150/5 mg/day	Drug	Aliskiren/amlodipine + Placebo to amlodipine
AmlodipineAmlodipine 5 mg/day.	Drug	Amlodipine + Placebo to aliskiren/amlodipine
Placebo to Aliskiren/amlodipinePlacebo to Aliskiren/amlodipine 150/10 mg/day	Drug	Amlodipine + Placebo to aliskiren/amlodipine
Placebo to AmlodipinePlacebo to Amlodipine 5 mg/day	Drug	Aliskiren/amlodipine + Placebo to amlodipine

Primary outcome

Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method
Time frame: Baseline, 4 weeks
AFV (mL) was measured using the principle of water displacement using a commercially available foot volumeter. The amount of water displaced in milliliters (mL) equals the volume of the foot/ankle. The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.

Results and safety

Results posted to the registry on 26 Dec 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aliskiren/Amlodipine + Placebo to Amlodipine	14	12
Amlodipine+ Placebo to Aliskiren/Amlodipine	17	16

Primary outcome: Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method

Time frame: Baseline, 4 weeks. Least squares mean (Standard Error). Unit: mL

Population analysed: The study was terminated due to the publication of the results of a near identical study by Fogari et al. Hence, for the current study, no analysis was performed.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aliskiren/Amlodipine and Placebo to Amlodipine	0 of 14 (0%)	2 of 14 (14.3%)	Not reported
Amlodipine and Placebo to Aliskiren/Amlodipine	0 of 17 (0%)	2 of 17 (11.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2011.
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 Pharmaceuticals study director

Novartis Pharmaceuticals

9 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/amlodipine and Amlodipine in people with Hypertension and Ankle Edema, run by Novartis Pharmaceuticals at 9 sites in Netherlands.

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 3 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 26 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in Netherlands. 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 26 Dec 2011). 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?

Change in the Ankle Foot Volume (AFV) as Measured by Displacement Method (time frame: Baseline, 4 weeks). 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 NCT01080768.

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 26 Dec 2011.