Essential HypertensionPhase 3NCT01001572

Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

A Phase 3 study testing Valsartan/amlodipine 160/5 mg and Valsartan 160 mg in people with Essential Hypertension, run by Novartis at 2 sites.

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

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and <110 mmHg) on valsartan 160 mg alone. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Essential Hypertension
What is being tested?: Valsartan/amlodipine 160/5 mg and Valsartan 160 mg
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 932 participants
Where: 2 sitesLocation not given
Study dates: Sep 2009to May 2010
Phase: Phase 3
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must give written informed consent
Male or female ages 18 or older and less than 86 years
Diagnosed as having essential diastolic hypertension, as follows:
Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and < 100 mmHg
At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP >=90 mmHg and <110 mmHg

Who cannot join

Severe hypertension
Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
Malignant hypertension
Administration of any agent indicated for the treatment of hypertension after Visit 1
Known moderate or malignant retinopathy.
Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures

Show all 10Show fewer

History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

2 sites in 1 country.

Location not given2 sites

Investigative site in Romainia
Novartis Investigative Site

About this study

Official title: A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy

Conditions: Essential Hypertension
Being tested: Valsartan/amlodipine 160/5 mg, Valsartan 160 mg, Placebo
Keywords: Blood pressure, hypertension, Exforge, valsartan/amlodipine
Medical subject headings: Essential Hypertension, Hypertension

What participants receive

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

Valsartan/amlodipine 160/5 mgDrug
Also called Exforge® 160/5mg
Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.
Valsartan 160 mgDrug
Also called Diovan® 160mg
Valsartan 160 mg capsule taken orally once daily.
PlaceboDrug
1 capsule or tablet taken orally once daily

Study groups in NCT01001572
Study group	Role	What they receive
Valsartan 160 mg	Active comparator	One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks Receives: Drug: Valsartan 160 mg; Drug: Placebo
Valsartan/amlodipine 160/5 mg	Experimental	One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks Receives: Drug: Valsartan/amlodipine 160/5 mg; Drug: Placebo
Single-Blind Run-In Valsartan 160 mg	Other	Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks. Receives: Drug: Valsartan 160 mg

What is being measured

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

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.
Measured: Baseline and Week 8

Secondary outcomes (4)

Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate
Measured: Baseline and Week 8
Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint
The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.
Measured: Baseline and Week 8
Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint
The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.
Measured: Week 8
Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint
The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.
Measured: Week 8

Timeline

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

Sep 2009May 2010

First posted26 Oct 2009 (estimated)
Study startSep 2009
Primary completionMay 2010
Study completionMay 2010

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 Essential 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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 932 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01001572
Sponsor's protocol ID: CVAA489A2317
Status last verified: May 2011
First submitted: 15 Oct 2009
Last updated: 24 May 2011
Results posted: Yes, on ClinicalTrials.gov

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?

See locations

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Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
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A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
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All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 24 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy
ClinicalTrials.gov ID: NCT01001572
Acronym / sponsor ID: CVAA489A2317
Conditions: Essential Hypertension
Keywords: Blood pressure, hypertension, Exforge, valsartan/amlodipine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 932 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Sep 2009
Primary completion: May 2010 (actual)
Study completion: May 2010 (actual)
First posted: 26 Oct 2009 (estimated)
Results: Posted 24 May 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: 3

Arm	Type	Receives
Valsartan 160 mg	Active comparator	Drug: Valsartan 160 mg, Drug: PlaceboOne capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks
Valsartan/amlodipine 160/5 mg	Experimental	Drug: Valsartan/amlodipine 160/5 mg, Drug: PlaceboOne film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks
Single-Blind Run-In Valsartan 160 mg	Other	Drug: Valsartan 160 mgSingle-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Patients must give written informed consent
Male or female ages 18 or older and less than 86 years
Diagnosed as having essential diastolic hypertension, as follows:

Key exclusion criteria (10 listed)

Severe hypertension
Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
Malignant hypertension
Administration of any agent indicated for the treatment of hypertension after Visit 1
Known moderate or malignant retinopathy.

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 160/5 mgAlso: Exforge® 160/5mgValsartan/amlodipine 160/5mg film coated tablets taken orally once daily.	Drug	Valsartan/amlodipine 160/5 mg
Valsartan 160 mgAlso: Diovan® 160mgValsartan 160 mg capsule taken orally once daily.	Drug	Single-Blind Run-In Valsartan 160 mg, Valsartan 160 mg
Placebo1 capsule or tablet taken orally once daily	Drug	Valsartan 160 mg, Valsartan/amlodipine 160/5 mg

Primary outcome

Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint
Time frame: Baseline and Week 8
Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.

4 secondary outcomes

Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint
Time frame: Baseline and Week 8
Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint
Time frame: Baseline and Week 8
Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint
Time frame: Week 8
Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint
Time frame: Week 8

Results and safety

Results posted to the registry on 24 May 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
Single-Blind Run -In Valsartan 160 mg	932	654
Valsartan/Amlodipine 160/5 mg	0	0
Valsartan 160 mg	0	0

Primary outcome: Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint

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

Measure	Valsartan/Amlodipine 160/5 mg n = 328	Valsartan 160 mg n = 323
Value	-10.3 (0.39)	-6.6 (0.40)

Population analysed: Full Analysis Set includes all randomized participants who had both baseline and at least one post-baseline efficacy measurement. Last Observation Carried Forward.

4 secondary outcomes are reported in the full results.

Adverse events

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

Group	Serious adverse events	Other adverse events	Deaths
Valsartan/Amlodipine 160/5 mg	0 of 329 (0%)	0 of 329 (0%)	Not reported
Valsartan 160 mg	1 of 325 (0.3%)	0 of 325 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Essential Hypertension

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
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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

Sponsor GmbH

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Valsartan/amlodipine 160/5 mg and Valsartan 160 mg in people with Essential Hypertension, run by Novartis at 2 sites.

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 5 inclusion and 10 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 24 May 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 24 May 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 in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint (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 NCT01001572.

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 24 May 2011.