HypertensionPhase 4NCT00441064

Effect of High and Low Sodium Diets on Blood Pressure in Hypertensive Patients Treated With Aliskiren

A Phase 4 study testing Aliskiren in people with Hypertension, run by Novartis at 19 sites in United States.

Completed

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

Trial summary

This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg. Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Hypertension
What is being tested?: Aliskiren
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 132 participants
Where: 19 sitesUnited States
Study dates: Jan 2007to Nov 2007
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 to 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female outpatients 18-60 years old
Patients with systolic hypertension who met the 24 hour Ambulatory Blood Pressure Monitoring (ABPM) criteria (ABPM mean daytime Systolic Blood Pressure (SBP) >= 135 mmHg and < 160 mmHg)

Who cannot join

Overt heart failure (HF) or a history of heart failure within preceding 6 months.
Unstable angina pectoris.
Type 1 or Type 2 diabetes mellitus or abnormal hemoglobin A1c(HbA1c)
Body mass index (BMI) > 30 kg/m2
Subjects taking more than 2 antihypertensive medications.
Use of other investigational drugs within 30 days of the time of enrollment

Show all 11Show fewer

Use of Tamsulosin hydrochloride and other alpha blockers.
Use of Antiarrhythmic drugs, including digoxin.
History of MI or cardiovascular attack (CVA) within the preceding 6 months.
History of malignancy of any organ system, treated or untreated, within the past 5 years with the exception of localized basal cell carcinoma of the skin
Pregnant or nursing (lactating) women

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Novartis US
Asheboro, North Carolina
Novartis US
Bountiful, Utah
Novartis US
Brooklyn Center, Minnesota
Novartis US
Butte, Montana
Novartis US
Cincinnati, Ohio
Novartis US
Dallas, Texas
Novartis US
Downington, Pennsylvania
Novartis US
Erie, Pennsylvania
Novartis US
Johnson City, New York
Novartis US
Kettering, Ohio
Novartis US
Kingsport, Texas
Novartis US
Lincoln, Nebraska
Novartis US
Madison, Wisconsin
Novartis US
Missoula, Montana
Novartis US
Orangevale, California
Novartis US
Pittsburgh, Pennsylvania
Novartis US
Port Orchard, Washington
Novartis US
Salt Lake City, Utah
Novartis US
Shelby, North Carolina

Other trials in United States

About this study

Official title: A Randomized, Open-label, Blinded Endpoint, Multi-center, Cross-over Study to Evaluate the Effect of High and Low Sodium Diets on Reduction in Mean 24-hour Ambulatory Blood Pressure in Systolic Hypertensive Patients Treated With Aliskiren (300 mg)

This study will compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.

Conditions: Hypertension
Being tested: Aliskiren
Keywords: High blood pressure, hypertension, aliskiren, low sodium diet
Medical subject headings: Hypertension

What participants receive

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

AliskirenDrug

Study groups in NCT00441064
Study group	Role	What they receive
Diet Sequence Low/High Sodium	Experimental	Patients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg] Receives: Drug: Aliskiren
Diet Sequence High/Low Sodium	Experimental	Patients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg] Receives: Drug: Aliskiren

What is being measured

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

Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet
The primary objective of the study was to assess mean 24 hour ambulatory systolic blood pressure (MASBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]
Measured: Week 4 and week 8 (4 weeks after crossover)

Secondary outcomes (2)

Mean 24 Hour Ambulatory Diastolic Blood Pressure (MADBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet
To evaluate the mean 24 hour ambulatory diastolic blood pressure (MADBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MADBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]
Measured: Week 4 and week 8 (4 weeks after crossover)
Percentage of Responders Defined as MASBP <130 mm Hg or a Decrease From Baseline in MASBP of ≥20 mm Hg in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet
To evaluate the percentage of responders defined as MASBP < 130 mm Hg or a decrease in MASBP from baseline of ≥20 mm Hg in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. Percent response for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]
Measured: Week 4 and Week 8 (4 weeks after crossover)

Timeline

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

Jan 2007Nov 2007

First posted28 Feb 2007 (estimated)
Study startJan 2007
Primary completionNov 2007
Study completionNov 2007

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: Crossover
Masking: None (open label)
Enrolment: 132 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00441064
Sponsor's protocol ID: CSPP100AUS02
Status last verified: Feb 2011
First submitted: 26 Feb 2007
Last updated: 25 Mar 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Weir MR, Yadao AM, Purkayastha D, Charney AN. Effects of high- and low-sodium diets on ambulatory blood pressure in patients with hypertension receiving aliskiren. J Cardiovasc Pharmacol Ther. 2010 Dec;15(4):356-63. doi: 10.1177/1074248410377173. Epub 2010 Sep 27.
PubMed 20876343

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 25 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Blinded Endpoint, Multi-center, Cross-over Study to Evaluate the Effect of High and Low Sodium Diets on Reduction in Mean 24-hour Ambulatory Blood Pressure in Systolic Hypertensive Patients Treated With Aliskiren (300 mg)
ClinicalTrials.gov ID: NCT00441064
Acronym / sponsor ID: CSPP100AUS02
Conditions: Hypertension
Keywords: High blood pressure, hypertension, aliskiren, low sodium diet
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 132 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Jan 2007
Primary completion: Nov 2007 (actual)
Study completion: Nov 2007 (actual)
First posted: 28 Feb 2007 (estimated)
Results: Posted 25 Mar 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 compare the effects of high and low level sodium (salt) diets on blood pressure in patients with hypertension (high blood pressure) who are taking aliskiren 300 mg.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Diet Sequence Low/High Sodium	Experimental	Drug: AliskirenPatients on low sodium diet ( <= 100 mmol/day) for the first 4 weeks and high sodium (>= 200 mmol/day) diet for the next 4 weeks. [with Aliskiren 300 mg]
Diet Sequence High/Low Sodium	Experimental	Drug: AliskirenPatients on high sodium (>= 200 mmol/day) diet for the first 4 weeks and on low sodium diet ( <= 100 mmol/day) for the next 4 weeks. [with Aliskiren 300 mg]

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (2 listed)

Male or female outpatients 18-60 years old
Patients with systolic hypertension who met the 24 hour Ambulatory Blood Pressure Monitoring (ABPM) criteria (ABPM mean daytime Systolic Blood Pressure (SBP) >= 135 mmHg and < 160 mmHg)

Key exclusion criteria (11 listed)

Overt heart failure (HF) or a history of heart failure within preceding 6 months.
Unstable angina pectoris.
Type 1 or Type 2 diabetes mellitus or abnormal hemoglobin A1c(HbA1c)
Body mass index (BMI) > 30 kg/m2
Subjects taking more than 2 antihypertensive medications.

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	Drug	Diet Sequence High/Low Sodium, Diet Sequence Low/High Sodium

Primary outcome

Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet
Time frame: Week 4 and week 8 (4 weeks after crossover)
The primary objective of the study was to assess mean 24 hour ambulatory systolic blood pressure (MASBP) in systolic hypertensive patients treated with aliskiren (300 mg) for 4 weeks on a high sodium diet versus 4 weeks on a low sodium diet. [At week 4 patients crossed over from low to high sodium diet and vice versa for 4 weeks. MASBP for patients on high sodium diet versus low sodium diet was also analyzed at week 8 (4 weeks after crossover).]

2 secondary outcomes

Mean 24 Hour Ambulatory Diastolic Blood Pressure (MADBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet
Time frame: Week 4 and week 8 (4 weeks after crossover)
Percentage of Responders Defined as MASBP <130 mm Hg or a Decrease From Baseline in MASBP of ≥20 mm Hg in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet
Time frame: Week 4 and Week 8 (4 weeks after crossover)

Results and safety

Results posted to the registry on 25 Mar 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
Diet Sequence Low/High Sodium	69	59
Diet Sequence High/Low Sodium	63	56

Primary outcome: Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet

Time frame: Week 4 and week 8 (4 weeks after crossover). Mean (Standard Deviation). Unit: mm Hg

Measure	Low Sodium Diet n = 115	High Sodium Diet n = 115
Period 1 (4 weeks)	124.8 (9.12)	134.7 (11.13)
Period 2 (next 4 weeks after crossover)	123.6 (11.69)	132.5 (10.07)

Population analysed: Completers Population: Included all patients who completed both diet periods - high and low sodium diets

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: AE's in overall Safety Population (SP) after 8 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Low Sodium Diet	0 of 126 (0%)	3 of 126 (2.4%)	Not reported
High Sodium Diet	0 of 124 (0%)	8 of 124 (6.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 20876343Weir MR, Yadao AM, Purkayastha D, Charney AN. Effects of high- and low-sodium diets on ambulatory blood pressure in patients with hypertension receiving aliskiren. J Cardiovasc Pharmacol Ther. 2010 Dec;15(4):356-63. doi: 10.1177/1074248410377173. Epub 2010 Sep 27.

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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 chair

Novartis

19 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 in people with Hypertension, run by Novartis at 19 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 11 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 25 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 19 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 25 Mar 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?

Mean 24 Hour Ambulatory Systolic Blood Pressure (MASBP) in Systolic Hypertensive Patients Treated With Aliskiren (300 mg) for 4 Weeks on a High Sodium Diet Versus 4 Weeks on a Low Sodium Diet (time frame: Week 4 and week 8 (4 weeks after crossover)). 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 NCT00441064, 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 25 Mar 2011.