HypertensionPhase 4EXPLORNCT00687973

Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg

A Phase 4 study testing Valsartan/amlodipine 80/5 mg tablets, Amlodipine 5 mg capsules and Amlodipine 10 mg capsules in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in France.

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

Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen. 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/amlodipine 80/5 mg tablets, Amlodipine 5 mg capsules and Amlodipine 10 mg capsules
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 393 participants
Where: 1 siteFrance
Study dates: Jan 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 or female patients 18 years of age or older
Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
Written informed consent to participate in the study prior to any study procedures

Who cannot join

Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
Evidence of a secondary form of hypertension
Type 1 diabetes mellitus
History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

Trial locations and contacts

1 site in 1 country.

France1 site

2 & 4 rue Lionel Terray BP 308
Rueil-Malmaison, 92506

Other trials in France

About this study

Conditions: Hypertension
Being tested: Valsartan/amlodipine 80/5 mg tablets, Amlodipine 5 mg capsules, Amlodipine 10 mg capsules, Atenolol 50 mg tablets, Atenolol 100 mg tablets
Medical subject headings: Hypertension

What participants receive

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

Valsartan/amlodipine 80/5 mg tabletsDrug
Amlodipine 5 mg capsulesDrug
Amlodipine 10 mg capsulesDrug
Atenolol 50 mg tabletsDrug
Atenolol 100 mg tabletsDrug

Study groups in NCT00687973
Study group	Role	What they receive
Valsartan/amlodipine 160/10 mg	Experimental	Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. Receives: Drug: Valsartan/amlodipine 80/5 mg tablets
Atenolol/amlodipine 100/10 mg	Active comparator	Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled. Receives: Drug: Amlodipine 5 mg capsules; Drug: Amlodipine 10 mg capsules; Drug: Atenolol 50 mg tablets; Drug: Atenolol 100 mg tablets

What is being measured

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

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
Measured: Baseline and Week 24

Secondary outcomes (10)

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)
Measured: Baseline and Week 8
Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)
Measured: Baseline and Week 24
Change From Baseline of Augmentation Index (Aix) at Week 8
To calculate the blood pressure augmentation index, the inflection point of the pressure curve corresponding to the return of the reflection wave was determined. The ratio between the pressure located above and below the inflection point was calculated.
Measured: Baseline and Week 8
Change From Baseline of Aix at Week 24
Measured: Baseline and Week 24
Change From Baseline of Aix Corrected to Heart Rate at Week 24
The heart rate correction was computed by a multivariate model analysis
Measured: Baseline and Week 24
Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)
Measured: Baseline and Week 24
Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)
Applanation tonometry is a measurement of aortic pressure and vascular stiffness. To assess the central aortic blood pressure, it is necessary to calibrate the applanation tonometry device using the brachial blood pressure.
Measured: Baseline and Week 24
Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)
Measured: Baseline and Week 24
Change From Baseline of SBP/DBP at Week 24 (Office BP)
Measured: Baseline and Week 24
Change From Baseline of Pulse Pressure at Week 24 (Office BP)
Measured: Baseline and Week 24

Timeline

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

Jan 2008Jan 2009

First posted2 Jun 2008 (estimated)
Study startJan 2008
Primary completionJan 2009
Study 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.
Other trials for HypertensionStudies of the same condition, open and under way.
More trials run by Novartis PharmaceuticalsThe sponsor's other registered studies.
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: None (open label)
Enrolment: 393 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00687973
Sponsor's protocol ID: CVAA489AFR02
Acronym: EXPLOR
Status last verified: Mar 2011
First submitted: 20 Mar 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: Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
ClinicalTrials.gov ID: NCT00687973
Acronym / sponsor ID: EXPLOR / CVAA489AFR02
Conditions: Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 393 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Jan 2008
Primary completion: Jan 2009 (actual)
Study completion: Jan 2009 (actual)
First posted: 2 Jun 2008 (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: None (open label)
Number of arms: 2

Arm	Type	Receives
Valsartan/amlodipine 160/10 mg	Experimental	Drug: Valsartan/amlodipine 80/5 mg tabletsPatients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
Atenolol/amlodipine 100/10 mg	Active comparator	Drug: Amlodipine 5 mg capsules, Drug: Amlodipine 10 mg capsules, Drug: Atenolol 50 mg tablets, Drug: Atenolol 100 mg tabletsPatients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.

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 or female patients 18 years of age or older
Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
Written informed consent to participate in the study prior to any study procedures

Key exclusion criteria (4 listed)

Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
Evidence of a secondary form of hypertension
Type 1 diabetes mellitus
History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.

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/amlodipine 80/5 mg tablets	Drug	Valsartan/amlodipine 160/10 mg
Amlodipine 5 mg capsules	Drug	Atenolol/amlodipine 100/10 mg
Amlodipine 10 mg capsules	Drug	Atenolol/amlodipine 100/10 mg
Atenolol 50 mg tablets	Drug	Atenolol/amlodipine 100/10 mg
Atenolol 100 mg tablets	Drug	Atenolol/amlodipine 100/10 mg

Primary outcome

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
Time frame: Baseline and Week 24

10 secondary outcomes

Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)
Time frame: Baseline and Week 8
Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)
Time frame: Baseline and Week 24
Change From Baseline of Augmentation Index (Aix) at Week 8
Time frame: Baseline and Week 8
Change From Baseline of Aix at Week 24
Time frame: Baseline and Week 24
Change From Baseline of Aix Corrected to Heart Rate at Week 24
Time frame: Baseline and Week 24
Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)
Time frame: Baseline and Week 24
Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)
Time frame: Baseline and Week 24
Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)
Time frame: Baseline and Week 24
Change From Baseline of SBP/DBP at Week 24 (Office BP)
Time frame: Baseline and Week 24
Change From Baseline of Pulse Pressure at Week 24 (Office BP)
Time frame: Baseline and Week 24

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
Valsartan/Amlodipine 160/10 mg	193	169
Atenolol/Amlodipine 100/10 mg	200	162

Primary outcome: Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)

Time frame: Baseline and Week 24. Least squares mean (Standard Error). Unit: mmHg

Measure	Valsartan/Amlodipine 160/10 mg n = 176	Atenolol/Amlodipine 100/10 mg n = 178
Value	-13.65 (1.15)	-9.7 (1.09)

Population analysed: Intent to treat (ITT) population; Last Observation Carried Forward (LOCF)

10 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
Amlodipine 5 mg	3 of 393 (0.8%)	10 of 393 (2.5%)	Not reported
Valsartan/Amlodipine 160/10 mg	4 of 193 (2.1%)	30 of 193 (15.5%)	Not reported
Atenolol/Amlodipine 100/10 mg	4 of 200 (2%)	31 of 200 (15.5%)	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 Valsartan/amlodipine 80/5 mg tablets, Amlodipine 5 mg capsules and Amlodipine 10 mg capsules in people with Hypertension, run by Novartis Pharmaceuticals at 1 site in France.

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 4 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 France. 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 of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement) (time frame: Baseline and Week 24). 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 NCT00687973.

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.