HypertensionPhase 4AACESSNCT00853957

Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine Versus Amlodipine Alone in African American Patients With Stage 2 Hypertension

A Phase 4 study testing Aliskiren/Amlodipine and Amlodipine in people with Hypertension, run by Novartis at 9 sites in United States.

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

The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: Aliskiren/Amlodipine and Amlodipine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 443 participants
Where: 9 sitesUnited States
Study dates: Feb 2009to Aug 2009
Phase: Phase 4
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women of African American background; self identified
Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization

Who cannot join

Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
Patients on 4 or more antihypertensive medications.
Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1
Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Evidence of a secondary form of hypertension, including but not limited to any of the following:

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coarctation of the aorta
hyperaldosteronism
unilateral or bilateral renal artery stenosis
Cushing's disease
polycystic kidney disease
pheochromocytoma
Known Keith-Wagener grade III or IV hypertensive retinopathy.
History of angioedema due to usage of an ARB or ACE inhibitor.
History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months
Other protocol defined inclusion/exclusion criteria applied

Trial locations and contacts

9 sites in 1 country.

City, postcode or hospital

9 sites in 1 country

United States9 sites

Investigative Site
Baltimore, Maryland
Investigative Site
Brooklyn, New York
Investigative Site
Chicago, Illinois
Investigative Site
Detroit, Michigan
Investigative Site
Milwaukeee, Wisconsin
Investigative Site
Oxon Hill, Maryland
Investigative Site
Philadelphia, Pennsylvania
Investigative Site
Springfield Gardens, New York
Investigative Site
Trenton, New Jersey

Other trials in United States

About this study

Official title: An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension

Conditions: Hypertension
Being tested: Aliskiren/Amlodipine, Amlodipine
Keywords: Hypertension, African Americans, Aliskiren, Amlodipine, Systolic blood pressure, Diastolic blood pressure, Stage II, Combination
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
Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
AmlodipineDrug
Amlodipine 5 mg titrated to 10mg

Study groups in NCT00853957
Study group	Role	What they receive
Aliskiren/Amlodipine	Experimental	Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg Receives: Drug: Aliskiren/Amlodipine
Amlodipine	Active comparator	Amlodipine 5mg titrated to 10 mg Receives: Drug: Amlodipine

What is being measured

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

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.
Measured: Baseline, 8 weeks

Secondary outcomes (5)

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
To compare the change from baseline in mean sitting diastolic blood pressure (msDBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg).
Measured: Baseline, 8 weeks
Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)
Cumulative percentage of patients achieving BP control (<140/90 mmHg)for both treatment arms was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Measured: 8 weeks
Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)
Cumulative percentage of responders (Responders are defined as patients with MSSBP <140 mmHg or a decrease from baseline ≥20 mmHg) during 8 weeks of treatment was calculated. Cumulative refers to achieving blood pressure control before or at the corresponding visit. If achieving blood pressure control occurred more than once, only the first occurrence was counted.
Measured: 8 weeks
Change From Baseline in MSSBP at Week 1 and 4
Compare the change from baseline in MSSBP at week 1 and 4
Measured: Baseline, 1 and 4 weeks
Percentage of Patients With Peripheral Edema by Visit
Cumulative percentage of patients with peripheral edema was calculated. 'Cumulative' refers to patients with peripheral edema before or at the corresponding visit. If peripheral edema occurred more than once, only the first occurrence was counted. Peripheral edema is the swelling of tissues due to the accumulation of fluids. Peripheral edema was assessed by investigators during physical examination.
Measured: 8 weeks

Timeline

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

Feb 2009Aug 2009

First posted2 Mar 2009 (estimated)
Study startFeb 2009
Primary completionAug 2009
Study completionAug 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.
Publications (1)Papers the sponsor has linked to this study.
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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 443 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00853957
Sponsor's protocol ID: CSPA100AUS01
Acronym: AACESS
Status last verified: Apr 2012
First submitted: 26 Feb 2009
Last updated: 30 Apr 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. doi: 10.1016/j.jash.2011.08.005. Epub 2011 Sep 17.
PubMed 21925996

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 30 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension
ClinicalTrials.gov ID: NCT00853957
Acronym / sponsor ID: AACESS / CSPA100AUS01
Conditions: Hypertension
Keywords: Hypertension, African Americans, Aliskiren, Amlodipine, Systolic blood pressure, Diastolic blood pressure, Stage II, Combination
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 443 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Feb 2009
Primary completion: Aug 2009 (actual)
Study completion: Aug 2009 (actual)
First posted: 2 Mar 2009 (estimated)
Results: Posted 21 Jan 2011

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/Amlodipine	Experimental	Drug: Aliskiren/AmlodipineAliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
Amlodipine	Active comparator	Drug: AmlodipineAmlodipine 5mg titrated to 10 mg

Who may qualify

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

Key inclusion criteria (2 listed)

Men or women of African American background; self identified
Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization

Key exclusion criteria (16 listed)

Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
Patients on 4 or more antihypertensive medications.
Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1
Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

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/AmlodipineAliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg	Drug	Aliskiren/Amlodipine
AmlodipineAmlodipine 5 mg titrated to 10mg	Drug	Amlodipine

Primary outcome

Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline, 8 weeks
To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.

5 secondary outcomes

Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: Baseline, 8 weeks
Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)
Time frame: 8 weeks
Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)
Time frame: 8 weeks
Change From Baseline in MSSBP at Week 1 and 4
Time frame: Baseline, 1 and 4 weeks
Percentage of Patients With Peripheral Edema by Visit
Time frame: 8 weeks

Results and safety

Results posted to the registry on 21 Jan 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	220	206
Amlodipine	223	204

Primary outcome: Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

Time frame: Baseline, 8 weeks. Mean (Standard Deviation). Unit: mm Hg

Measure	Aliskiren/Amlodipine n = 220	Amlodipine n = 222
Value	-33.1 (14.53)	-27.8 (13.45)

Population analysed: Full analysis set, Last Observation Carried Forward (LOCF)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aliskiren/Amlodipine	1 of 220 (0.5%)	25 of 220 (11.4%)	Not reported
Amlodipine	1 of 223 (0.4%)	31 of 223 (13.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21925996Weinberger MH, Izzo JL Jr, Purkayastha D, Weitzman R, Black HR. Comparative efficacy and safety of combination aliskiren/amlodipine and amlodipine monotherapy in African Americans with stage 2 hypertension and obesity or metabolic syndrome. J Am Soc Hypertens. 2011 Nov-Dec;5(6):489-97. doi: 10.1016/j.jash.2011.08.005. Epub 2011 Sep 17.

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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 study director

Novartis

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Aliskiren/Amlodipine and Amlodipine in people with Hypertension, run by Novartis at 9 sites in United States.

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 2 inclusion and 16 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 30 Apr 2012. 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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 21 Jan 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 From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) (time frame: Baseline, 8 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 NCT00853957, which also lists 1 linked publication.

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 30 Apr 2012.