HypertensionPhase 4AIMSNCT00797316

Aliskiren Plus HCTZ Compared to Aliskiren in Metabolic Syndrome Patients With Stage 2 Systolic Hypertension

A Phase 4 study testing Aliskiren and Hydrochlorothiazide in people with Hypertension, run by Novartis at 1 site 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 blood pressure lowering effect and safety of aliskiren in combination with Hydrochlorothiazide (HCTZ) compared to aliskiren monotherapy when given to metabolic syndrome patients with stage 2 systolic hypertension (mean sitting systolic blood pressure [msSBP] ≥ 160 mm Hg and… 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 and Hydrochlorothiazide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 532 participants
Where: 1 siteUnited States
Study dates: Nov 2008to Dec 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

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Male or female outpatients ≥ 18 years old.
Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and <200 mmHg at Study Visit 5 (randomization).
Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:
Abdominal obesity (waist circumference > than 102 cm for men and > 88 cm for women)
Current triglycerides ≥ 150 mg/dL or medical treatment for this condition.
Current HDL- Cholesterol <40 mg/dL in men and <50 mg/dL in women or medical treatment for this condition.
Fasting glucose >100 mg/dL and <126 mg/dL

Who cannot join

Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
History or evidence of secondary form of hypertension.
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 (140/90mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
Patients on 4 or more antihypertensive medications.

Trial locations and contacts

1 site in 1 country.

United States1 site

Novartis Pharmaceuticals
East Hanover, New Jersey, 07936

Other trials in United States

About this study

Official title: An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Forced-titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension

Conditions: Hypertension
Being tested: Aliskiren, Hydrochlorothiazide
Keywords: Hypertension, Metabolic Syndrome, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, stage 2
Medical subject headings: Hypertension, Metabolic Syndrome

What participants receive

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

AliskirenDrug
Aliskiren 150 mg or 300 mg taken once daily in oral form
HydrochlorothiazideDrug
Hydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.

Study groups in NCT00797316
Study group	Role	What they receive
Aliskiren plus Hydrochlorothiazide	Experimental	Aliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form. Receives: Drug: Aliskiren; Drug: Hydrochlorothiazide
Aliskiren	Active comparator	Aliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form. Receives: Drug: Aliskiren

What is being measured

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

Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)
Measured: Baseline and Week 8

Secondary outcomes (4)

Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)
Measured: 8 weeks
Percentage of Participants With Blood Pressure Response at Week 8
Response is defined as a patient with msSBP < 140 mmHg or a decrease from baseline ≥ 20 mmHg in msSBP during eight weeks of treatment.
Measured: 8 weeks
Percentage of Patients Achieving Blood Pressure Control at Week 8
Blood pressure control is defined as a patient who achieves a target Blood Pressure of mean sitting Systolic Blood Pressure / mean sitting Diastolic Blood pressure < 140/90 mmHg.
Measured: 8 weeks
Change From Baseline to Week 8 in Pulse Pressure
Measured: Baseline and Week 8

Timeline

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

Nov 2008Dec 2009

First posted25 Nov 2008 (estimated)
Study startNov 2008
Primary completionDec 2009
Study completionDec 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 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 532 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00797316
Sponsor's protocol ID: CSPP100A2410
Acronym: AIMS
Status last verified: Mar 2011
First submitted: 24 Nov 2008
Last updated: 11 Mar 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 11 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Forced-titration Study to Evaluate the Efficacy and Safety of Aliskiren Plus HCTZ Compared to Aliskiren Monotherapy in Metabolic Syndrome Patients With Stage 2 Hypertension
ClinicalTrials.gov ID: NCT00797316
Acronym / sponsor ID: AIMS / CSPP100A2410
Conditions: Hypertension
Keywords: Hypertension, Metabolic Syndrome, aliskiren, hydrochlorothiazide, systolic blood pressure, diastolic blood pressure, stage 2
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 532 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Dec 2009 (actual)
Study completion: Dec 2009
First posted: 25 Nov 2008 (estimated)
Results: Posted 12 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 plus Hydrochlorothiazide	Experimental	Drug: Aliskiren, Drug: HydrochlorothiazideAliskiren (150 mg) plus Hydrochlorothiazide (12.5 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg) plus Hydrochlorothiazide (25 mg). Medication was taken once daily in oral form.
Aliskiren	Active comparator	Drug: AliskirenAliskiren (150 mg) for one week. Subsequently up-titrated to Aliskiren (300 mg). Medication was taken once daily in oral form.

Who may qualify

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

Key inclusion criteria (8 listed)

Patients who are eligible and able to participate in the study, and who give written informed consent before any assessment is performed.
Male or female outpatients ≥ 18 years old.
Patients with stage 2 systolic hypertension. Patients must have a msSBP ≥160 mmHg and <200 mmHg at Study Visit 5 (randomization).
Patients who have stage 2 systolic hypertension that meet at least 2 additional components of the metabolic syndrome as defined by the National *Cholesterol Education program (NCEP) criteria:

Key exclusion criteria (7 listed)

Office blood pressure measured by cuff (msDBP ≥ 110 mmHg and or msSBP ≥ 200 mmHg) at any visit.
Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of enrollment, whichever is longer.
Use of aliskiren and/or a fixed dose combination of aliskiren HCTZ or participation in a clinical trial that had aliskiren and/or aliskiren HCTZ as treatment within 30 days of Visit 1.
History of hypersensitivity to any of the medications or to drugs belonging to a similar therapeutic class (diuretics or renin inhibitors) as the study drugs.
History or evidence of secondary form of hypertension.

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
AliskirenAliskiren 150 mg or 300 mg taken once daily in oral form	Drug	Aliskiren, Aliskiren plus Hydrochlorothiazide
HydrochlorothiazideHydrochlorothiazide 12.5 mg or 25 mg taken once daily in oral form.	Drug	Aliskiren plus Hydrochlorothiazide

Primary outcome

Change From Baseline to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP)
Time frame: Baseline and Week 8

4 secondary outcomes

Change From Baseline to Week 8 in Mean Sitting Diastolic Blood Pressure (msDBP)
Time frame: 8 weeks
Percentage of Participants With Blood Pressure Response at Week 8
Time frame: 8 weeks
Percentage of Patients Achieving Blood Pressure Control at Week 8
Time frame: 8 weeks
Change From Baseline to Week 8 in Pulse Pressure
Time frame: Baseline and Week 8

Results and safety

Results posted to the registry on 12 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/HCTZ	267	244
Aliskiren	265	233

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

Time frame: Baseline and Week 8. Least squares mean (Standard Error). Unit: mm Hg

Measure	Aliskiren/HCTZ n = 264	Aliskiren n = 261
Value	-30.38 (1.01)	-20.15 (1.01)

Population analysed: Full analysis set

4 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
Aliskiren/HCTZ	3 of 267 (1.1%)	13 of 267 (4.9%)	Not reported
Aliskiren	4 of 265 (1.5%)	18 of 265 (6.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 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

1 site 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 and Hydrochlorothiazide in people with Hypertension, run by Novartis at 1 site 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 8 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: finished, as of the sponsor's last update on 11 Mar 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 12 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 to Week 8 in Mean Sitting Systolic Blood Pressure (msSBP) (time frame: Baseline and 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 NCT00797316.

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 11 Mar 2011.