HypertensionPhase 3NCT00706134

Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal in a 8 Week Placebo-controlled Study

A Phase 3 study testing Aliskiren 75 mg, Aliskiren 150 mg and Aliskiren 300 mg in people with Hypertension, run by Novartis at 8 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal. Read more about this study

Who is it for?: Ages 65 years and older
Conditions the study is for: Hypertension
What is being tested?: Aliskiren 75 mg, Aliskiren 150 mg and Aliskiren 300 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 756 participants
Where: 8 sitesin 8 countries
Study dates: May 2008to Apr 2009
Phase: Phase 3
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 65 years and older
All sexes
No healthy volunteers
Older adult

Who may be able to join

Male and female outpatients 65 years of age and older.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Who cannot join

Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
History or evidence of a secondary form of hypertension.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
Current diagnosis of heart failure (NYHA Class II-IV).
History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
Current angina pectoris requiring pharmacological therapy other than nitrates.
Other protocol-defined inclusion/exclusion criteria applied to the study.

Trial locations and contacts

8 sites in 8 countries.

Country

City, postcode or hospital

8 sites in 8 countries

Argentina1 site

Investigative Site
Buenos Aires

Other trials in Argentina

Czechia1 site

Investigative Site
Prague

Other trials in Czechia

Germany1 site

Investigative Site
Berlin

Other trials in Germany

Iceland1 site

Investigative Site
Reykjavik

Other trials in Iceland

Italy1 site

Investigative Site
Rome

Other trials in Italy

Netherlands1 site

Investigative Site
Amsterdam

Other trials in Netherlands

Poland1 site

Investigative Site
Warsaw

Other trials in Poland

Slovakia1 site

Investigative Site
Bratislava

Other trials in Slovakia

About this study

Official title: An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

Conditions: Hypertension
Being tested: Placebo, Aliskiren 75 mg, Aliskiren 150 mg, Aliskiren 300 mg
Keywords: Hypertension, ≥ 65 years, aliskiren, placebo, light meal
Medical subject headings: Hypertension

What participants receive

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

PlaceboDrug
Placebo tablet taken once daily in the morning with a light meal.
Aliskiren 75 mgDrug
Aliskiren 75 mg tablet taken once daily in the morning with a light meal.
Aliskiren 150 mgDrug
Aliskiren 150 mg tablet taken once daily in the morning with a light meal.
Aliskiren 300 mgDrug
Aliskiren 300 mg tablet taken once daily in the morning with a light meal.

Study groups in NCT00706134
Study group	Role	What they receive
Placebo	Placebo comparator	Not described Receives: Drug: Placebo
Aliskiren 75 mg	Experimental	Not described Receives: Drug: Aliskiren 75 mg
Aliskiren 150 mg	Experimental	Not described Receives: Drug: Aliskiren 150 mg
Aliskiren 300 mg	Experimental	Not described Receives: Drug: Aliskiren 300 mg

What is being measured

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

Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
Measured: Baseline to end of study (Week 8)

Secondary outcomes (5)

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Measured: Baseline to end of study (Week 8)
Percentage of Patients Achieving Systolic Blood Pressure Response
Patients achieving a systolic blood pressure response had to have a msSBP < 140 mmHg at the end of the study and/or a ≥ 20 mmHg reduction in msSBP from baseline to the end of the study.
Measured: Baseline to end of study (Week 8)
Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study
Two 24-hour ambulatory blood pressure monitoring (ABPM) evaluations were performed, one at baseline and one at the end of the study. For each evaluation, the ABPM device was attached to the non-dominant arm of the patient.
Measured: Baseline to end of study (Week 8)
Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
Smoothness index (SI) is a measure of consistency of the BP reduction over 24 hours. The SI was obtained by first calculating the mean blood pressure value at each hour of the 24-hour ambulatory blood pressure monitoring period, both before and during treatment. Similarly, the change from baseline in blood pressure was calculated at each hour. The average hourly change from baseline (δh) and standard deviation (std δh) of the hourly changes were computed, and the SI was derived: SI = δh/std δh. A negative change score indicates improvement.
Measured: Baseline to end of study (Week 8)
Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
The morning surge was defined as the average of the hourly means in the last three hours (hours 22, 23, 24) of the 24 hour ambulatory blood pressure monitoring assessment period.
Measured: Baseline to end of study (week 8)

Timeline

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

May 2008Apr 2009

First posted27 Jun 2008 (estimated)
Study startMay 2008
Primary completionApr 2009
Study completionApr 2009

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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 756 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00706134
Sponsor's protocol ID: CSPP100A2405
Status last verified: Jun 2011
First submitted: 25 Jun 2008
Last updated: 28 Jun 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 28 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal
ClinicalTrials.gov ID: NCT00706134
Acronym / sponsor ID: CSPP100A2405
Conditions: Hypertension
Keywords: Hypertension, ≥ 65 years, aliskiren, placebo, light meal
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 756 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: May 2008
Primary completion: Apr 2009 (actual)
Study completion: Apr 2009 (actual)
First posted: 27 Jun 2008 (estimated)
Results: Posted 17 Jun 2011

Clinical summary

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

This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Placebo	Placebo comparator	Drug: Placebo
Aliskiren 75 mg	Experimental	Drug: Aliskiren 75 mg
Aliskiren 150 mg	Experimental	Drug: Aliskiren 150 mg
Aliskiren 300 mg	Experimental	Drug: Aliskiren 300 mg

Who may qualify

Ages: 65 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Older adult

Key inclusion criteria (3 listed)

Male and female outpatients 65 years of age and older.
Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.

Key exclusion criteria (8 listed)

Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
History or evidence of a secondary form of hypertension.
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
Current diagnosis of heart failure (NYHA Class II-IV).

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
PlaceboPlacebo tablet taken once daily in the morning with a light meal.	Drug	Placebo
Aliskiren 75 mgAliskiren 75 mg tablet taken once daily in the morning with a light meal.	Drug	Aliskiren 75 mg
Aliskiren 150 mgAliskiren 150 mg tablet taken once daily in the morning with a light meal.	Drug	Aliskiren 150 mg
Aliskiren 300 mgAliskiren 300 mg tablet taken once daily in the morning with a light meal.	Drug	Aliskiren 300 mg

Primary outcome

Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (Week 8)

5 secondary outcomes

Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Percentage of Patients Achieving Systolic Blood Pressure Response
Time frame: Baseline to end of study (Week 8)
Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study
Time frame: Baseline to end of study (Week 8)
Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (Week 8)
Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)
Time frame: Baseline to end of study (week 8)

Results and safety

Results posted to the registry on 17 Jun 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
Placebo	189	169
Aliskiren 75 mg	192	173
Aliskiren 150 mg	189	183
Aliskiren 300 mg	186	175

Primary outcome: Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)

Time frame: Baseline to end of study (Week 8). Least squares mean (Standard Error). Unit: mmHg

Measure	Placebo n = 184	Aliskiren 75 mg n = 192	Aliskiren 150 mg n = 188	Aliskiren 300 mg n = 186
Value	-7.97 (1.043)	-12.51 (1.024)	-15.28 (1.035)	-14.14 (1.042)

Population analysed: Full analysis set (FAS) - All randomized patients. Two randomized patients who did not meet study criteria were excluded from the FAS.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: End of study (week 8). Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	1 of 186 (0.5%)	0 of 186 (0%)	Not reported
Aliskiren 75 mg	2 of 191 (1%)	0 of 191 (0%)	Not reported
Aliskiren 150 mg	3 of 189 (1.6%)	0 of 189 (0%)	Not reported
Aliskiren 300 mg	0 of 188 (0%)	0 of 188 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 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.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 8 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Aliskiren 75 mg, Aliskiren 150 mg and Aliskiren 300 mg in people with Hypertension, run by Novartis at 8 sites in 8 countries.

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 8 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: finished, as of the sponsor's last update on 28 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Argentina, Czechia, Germany, Iceland, Italy and 3 more countries. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Jun 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 Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8) (time frame: Baseline to end of study (Week 8)). 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 NCT00706134.

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 28 Jun 2011.