HypertensionPhase 4EXTRANCT00666536

The Effects of Moderate vs. Aggressive Treatment With Valsartan + Amlodipine on Patients With Hypertension Uncontrolled by Angiotensin-Receptor Blocker (Herein, ARB) Monotherapy

A Phase 4 study testing valsartan and amlodipine 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 this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hypertension
What is being tested?: valsartan and amlodipine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 728 participants
Where: 1 siteUnited States
Study dates: Mar 2008to Jan 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

Male and female outpatients
18 Years of age or older
Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Who cannot join

Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

Trial locations and contacts

1 site in 1 country.

United States1 site

Egan Healthcare
Metairie, Louisiana, 70002

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy

Conditions: Hypertension
Being tested: valsartan and amlodipine
Keywords: Hypertension, adults, Valsartan + Amlodipine, Angiotensin Receptor Blockers
Medical subject headings: Hypertension

What participants receive

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

valsartan and amlodipineDrug
valsartan and amlodipineDrug

Study groups in NCT00666536
Study group	Role	What they receive
Aggressive treatment regimen (5/320 mg to 10/320 mg)	Active comparator	Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) Receives: Drug: valsartan and amlodipine
Moderate treatment regimen (5/160 mg)	Active comparator	Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks) Receives: Drug: valsartan and amlodipine

What is being measured

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

Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
Measured: Baseline and Week 4

Secondary outcomes (5)

Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Measured: Weeks 2, 4, 8 and 12
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
Measured: Baseline and Week 4
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Measured: Baseline and Weeks 2, 8 and 12
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Measured: Baseline and Weeks 2, 8 and 12
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Measured: Weeks 2, 4, 8 and 12

Timeline

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

Mar 2008Jan 2009

First posted25 Apr 2008 (estimated)
Study startMar 2008
Primary completionJan 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 (2)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: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 728 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00666536
Sponsor's protocol ID: CVAA489AUS02
Acronym: EXTRA
Status last verified: Apr 2011
First submitted: 23 Apr 2008
Last updated: 27 Oct 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Oparil S, Giles T, Ofili EO, Pitt B, Seifu Y, Hilkert R, Samuel R, Sowers JR. Moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. J Hypertens. 2011 Jan;29(1):161-70. doi: 10.1097/HJH.0b013e32834000a7.
PubMed 21045734
Giles TD, Oparil S, Ofili EO, Pitt B, Purkayastha D, Hilkert R, Samuel R, Sowers JR. The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. Blood Press Monit. 2011 Apr;16(2):87-95. doi: 10.1097/MBP.0b013e328344c713.
PubMed 21386706

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 27 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy
ClinicalTrials.gov ID: NCT00666536
Acronym / sponsor ID: EXTRA / CVAA489AUS02
Conditions: Hypertension
Keywords: Hypertension, adults, Valsartan + Amlodipine, Angiotensin Receptor Blockers
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 728 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Mar 2008
Primary completion: Jan 2009 (actual)
First posted: 25 Apr 2008 (estimated)
Results: Posted 10 Dec 2010

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: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Aggressive treatment regimen (5/320 mg to 10/320 mg)	Active comparator	Drug: valsartan and amlodipineValsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
Moderate treatment regimen (5/160 mg)	Active comparator	Drug: valsartan and amlodipineValsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)

Who may qualify

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

Key inclusion criteria (3 listed)

Male and female outpatients
18 Years of age or older
Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization

Key exclusion criteria (3 listed)

Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)

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
valsartan and amlodipine	Drug	Aggressive treatment regimen (5/320 mg to 10/320 mg)
valsartan and amlodipine	Drug	Moderate treatment regimen (5/160 mg)

Primary outcome

Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
Time frame: Baseline and Week 4

5 secondary outcomes

Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12
Time frame: Weeks 2, 4, 8 and 12
Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)
Time frame: Baseline and Week 4
Change From Baseline to Weeks 2, 8 and 12 in MSSBP
Time frame: Baseline and Weeks 2, 8 and 12
Change From Baseline to Weeks 2, 8 and 12 in MSDBP
Time frame: Baseline and Weeks 2, 8 and 12
Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12
Time frame: Weeks 2, 4, 8 and 12

Results and safety

Results posted to the registry on 10 Dec 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)	369	336
Moderate Treatment Regimen (5/160 mg)	359	322

Primary outcome: Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)

Time frame: Baseline and Week 4. Mean (Standard Deviation). Unit: mmHg

Measure	Aggressive Treatment Regimen (5/320 mg to 10/320 mg) n = 366	Moderate Treatment Regimen (5/160 mg) n = 357
Baseline MSSBP	163.9 (11.85)	163.3 (11.40)
Week 4 MSSBP	140.9 (14.61)	144.4 (14.21)
Change From Baseline to Week 4 in MSSBP	-23.0 (14.60)	-18.9 (13.92)

Population analysed: Intent to treat (ITT), Last observation carried forward (LOCF)

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Aggressive Treatment Regimen (5/320 mg to 10/320 mg)	4 of 369 (1.1%)	50 of 369 (13.6%)	Not reported
Moderate Treatment Regimen (5/160 mg)	10 of 359 (2.8%)	29 of 359 (8.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21045734Oparil S, Giles T, Ofili EO, Pitt B, Seifu Y, Hilkert R, Samuel R, Sowers JR. Moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. J Hypertens. 2011 Jan;29(1):161-70. doi: 10.1097/HJH.0b013e32834000a7.
Derived from this study: PubMed 21386706Giles TD, Oparil S, Ofili EO, Pitt B, Purkayastha D, Hilkert R, Samuel R, Sowers JR. The role of ambulatory blood pressure monitoring compared with clinic and home blood pressure measures in evaluating moderate versus intensive treatment of hypertension with amlodipine/valsartan for patients uncontrolled on angiotensin receptor blocker monotherapy. Blood Press Monit. 2011 Apr;16(2):87-95. doi: 10.1097/MBP.0b013e328344c713.

Related trials for Hypertension

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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.

Suzanne Oparil, MD et al principal investigator

University of Alabama at Birmingham

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 valsartan and amlodipine 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 3 inclusion and 3 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 27 Oct 2016. 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 10 Dec 2010). 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 4 in Mean Sitting Systolic Blood Pressure (MSSBP) (time frame: Baseline and Week 4). 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 NCT00666536, which also lists 2 linked publications.

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 27 Oct 2016.