Hypertension; Hypertrophy, Left VentricularPhase 3NCT00446563

Efficacy and Safety of Valsartan in Combination With Amlodipine Compared to Losartan Plus Hydrochlorothiazide in Patients With Hypertension and Left Ventricular Hypertrophy

A Phase 3 study testing Valsartan, Amlodipine and Hydrochlorothiazide in people with Hypertension; Hypertrophy, Left Ventricular, run by Novartis at 1 site in Germany.

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 will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertension; Hypertrophy, Left Ventricular
What is being tested?: Valsartan, Amlodipine and Hydrochlorothiazide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 90 participants
Where: 1 siteGermany
Study dates: Mar 2007to Mar 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 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg.
Patients with Left Ventricular Hypertrophy

Who cannot join

Severe hypertension
Symptomatic heart failure
History of stroke, heart attack, coronary bypass surgery etc.
Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.
Other protocol-defined inclusion/exclusion criteria may apply

Trial locations and contacts

1 site in 1 country.

Germany1 site

25 centers in Germany
Ludwigshafen

Other trials in Germany

About this study

Official title: An Open-label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy in Patients With Mild to Moderate Hypertension

This study will evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy

Conditions: Hypertension; Hypertrophy, Left Ventricular
Being tested: Valsartan, Amlodipine, Hydrochlorothiazide, Losartan
Keywords: Left ventricular hypertrophy, hypertension, valsartan, amlodipine
Medical subject headings: Hypertension, Hypertrophy, Hypertrophy, Left Ventricular

What participants receive

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

ValsartanDrug
160 mg film coated tablets taken orally once daily in the morning.
AmlodipineDrug
5 mg or 10 mg tablets taken orally once daily in the morning.
HydrochlorothiazideDrug
12.5 mg or 25 mg tablets taken orally once daily in the morning.
LosartanDrug
100 mg tablets taken orally once daily in the morning.

Study groups in NCT00446563
Study group	Role	What they receive
Amlodipine + Valsartan	Experimental	Participants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication. Receives: Drug: Valsartan; Drug: Amlodipine
Losartan + Hydrochlorothiazide	Active comparator	Participants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication. Receives: Drug: Hydrochlorothiazide; Drug: Losartan

What is being measured

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

Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
Measured: Baseline to week 52

Secondary outcomes (14)

Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
Ejection fraction is a measurement of the percentage of blood that is pumped out of a filled ventricle with each heartbeat.
Measured: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
Measured: Baseline to week 52
Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)
Measured: Baseline to week 52
Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
Measured: Baseline to week 52
Percentage of Participants Achieving Target Blood Pressure at Week 52
Target blood pressure defined as having a mean sitting systolic blood pressure (MSSBP) < 140 mm Hg and a mean sitting diastolic blood pressure (MSDBP) < 90 mm Hg.
Measured: Week 52
Percentage of Participants Who Experienced Adverse Events (AEs)
An adverse event was the appearance or worsening of any undesirable sign, symptom, or medical condition occurring after obtaining informed consent even if the event was not considered to be related to study drug. Medical conditions/diseases present before obtaining informed consent were only considered adverse events if they worsened after study start. Abnormal laboratory values or test results constituted adverse events only if they induced clinical signs or symptoms, required study drug discontinuation or required therapy.
Measured: Baseline to week 52

Timeline

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

Mar 2007Mar 2010

First posted13 Mar 2007 (estimated)
Study startMar 2007
Primary completionMar 2010
Study completionMar 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypertension; Hypertrophy, Left VentricularStudies 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: None (open label)
Enrolment: 90 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00446563
Sponsor's protocol ID: CVAA489ADE02
Status last verified: May 2011
First submitted: 12 Mar 2007
Last updated: 11 May 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Bruder O, Jensen CJ, Bell M, Rummel R, Boehm G, Klebs S, Sieder C, Senges J. Effects of the combinations of amlodipine/valsartan versus losartan/hydrochlorothiazide on left ventricular hypertrophy as determined with magnetic resonance imaging in patients with hypertension. J Drug Assess. 2011 Dec 16;1(1):1-10. doi: 10.3109/21556660.2011.639418. eCollection 2012.
PubMed 27536421

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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All Hypertension; Hypertrophy, Left Ventricular trials

Study at a glance

From the registry record, last updated by the sponsor on 11 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Parallel Group Study Comparing the Efficacy and Safety of Amlodipine in Combination With Valsartan Compared to Losartan in Combination With Hydrochlorothiazide Given for 52 Weeks on the Regression of Left Ventricular Hypertrophy in Patients With Mild to Moderate Hypertension
ClinicalTrials.gov ID: NCT00446563
Acronym / sponsor ID: CVAA489ADE02
Conditions: Hypertension; Hypertrophy, Left Ventricular
Keywords: Left ventricular hypertrophy, hypertension, valsartan, amlodipine
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 90 participants (actual)
Lead sponsor: NovartisIndustry (pharma, biotech, devices)
Study start: Mar 2007
Primary completion: Mar 2010 (actual)
Study completion: Mar 2010 (actual)
First posted: 13 Mar 2007 (estimated)
Results: Posted 27 Apr 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 evaluate the safety and efficacy of amlodipine plus valsartan in patients with hypertension and left ventricular hypertrophy

Study design

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

Arm	Type	Receives
Amlodipine + Valsartan	Experimental	Drug: Valsartan, Drug: AmlodipineParticipants received 160 mg Valsartan and 5 mg amlodipine orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to valsartan/amlodipine 160/10 mg. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.
Losartan + Hydrochlorothiazide	Active comparator	Drug: Hydrochlorothiazide, Drug: LosartanParticipants received 100 mg losartan and 12.5 mg Hydrochlorothiazide (HCT) orally once a day for 52 weeks. If blood pressure was not normalized at week 4, treatment was uptitrated to losartan/HCT 100/25 mg, respectively, until end of study. Participants with still uncontrolled hypertension could receive add-on antihypertensive medication.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

Caucasian; male or female outpatients and age between 18-80 years of age, inclusive.
Patients with a history of essential hypertension and who are actually treated either with an antihypertensive monotherapy and with a diastolic blood pressure >=90 and <= 105mmHg or with a combination therapy (limited to two active compounds) and with a diastolic blood pressure of >=90 and <= 100mmHg.
Patients with Left Ventricular Hypertrophy

Key exclusion criteria (5 listed)

Severe hypertension
Symptomatic heart failure
History of stroke, heart attack, coronary bypass surgery etc.
Insulin-dependent diabetes mellitus or poorly controlled diabetes mellitus.
Other protocol-defined inclusion/exclusion criteria may apply

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
Valsartan160 mg film coated tablets taken orally once daily in the morning.	Drug	Amlodipine + Valsartan
Amlodipine5 mg or 10 mg tablets taken orally once daily in the morning.	Drug	Amlodipine + Valsartan
Hydrochlorothiazide12.5 mg or 25 mg tablets taken orally once daily in the morning.	Drug	Losartan + Hydrochlorothiazide
Losartan100 mg tablets taken orally once daily in the morning.	Drug	Losartan + Hydrochlorothiazide

Primary outcome

Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)
Time frame: Baseline to week 52

14 secondary outcomes

Change From Baseline to the End of Study in Left Ventricular Mass Index (LVMI) Normalized to Body Surface Area Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Interventricular Septum Thickness (IVS) Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Posterior Wall Thickness Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular Ejection Fraction (LVEF) Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-diastolic Volume (LVEDV) Normalized to Body Surface Area Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Ventricular End-Systolic Volume (LVESV) Normalized to Body Surface Area Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in Left Atrial (LA) Area Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to the End of Study in the Ascending Aortic Diameter Assessed by MRI
Time frame: Baseline to week 52
Change From Baseline to End of Study in Levels of N-terminal Pro-B Type Natriuretic Peptide (NT-proBNP)
Time frame: Baseline to week 52
Change From Baseline to End of Study in Levels of High-sensitivity C-reactive Protein (Hs-CRP)
Time frame: Baseline to week 52
Percentage of Participants Achieving Target Blood Pressure at Week 52
Time frame: Week 52
Percentage of Participants Who Experienced Adverse Events (AEs)
Time frame: Baseline to week 52

Results and safety

Results posted to the registry on 27 Apr 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 and Amlodipine	43	36
Losartan and HCTZ	47	38

Primary outcome: Change From Baseline in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI)

Time frame: Baseline to week 52. Mean (Standard Deviation). Unit: g/m˄2

Measure	Valsartan and Amlodipine n = 43	Losartan and HCTZ n = 47
Value	-7.1 (16.50)	-9.1 (18.89)

Population analysed: The intention-to-treat (ITT) population consisted of all patients who had a baseline MRI assessment. If patients dropped out prior to the scheduled observation period, every effort should have been taken to get a final MRI scan which could then be used for the ITT analysis.

14 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
Valsartan and Amlodipine	2 of 43 (4.7%)	15 of 43 (34.9%)	Not reported
Losartan and HCTZ	6 of 47 (12.8%)	16 of 47 (34%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27536421Bruder O, Jensen CJ, Bell M, Rummel R, Boehm G, Klebs S, Sieder C, Senges J. Effects of the combinations of amlodipine/valsartan versus losartan/hydrochlorothiazide on left ventricular hypertrophy as determined with magnetic resonance imaging in patients with hypertension. J Drug Assess. 2011 Dec 16;1(1):1-10. doi: 10.3109/21556660.2011.639418. eCollection 2012.

Related trials for Hypertension; Hypertrophy, Left Ventricular

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A Health Coach-Led Digital Lifestyle Intervention (HEALDI)
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RecruitingPhase 4
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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

1 site 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 and Hydrochlorothiazide in people with Hypertension; Hypertrophy, Left Ventricular, run by Novartis at 1 site in Germany.

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 5 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 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 1 site in Germany. 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 27 Apr 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 in Left Ventricular Mass Index (LVMI) Measured Via Magnetic Resonance Imaging (MRI) (time frame: Baseline to week 52). 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 NCT00446563, 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 11 May 2011.