Essential HypertensionPhase 4NCT02062645

Study of Efficacy and Safety of CVAA489 in Hypertensive Patients

A Phase 4 study testing amlodipine/valsartan in people with Essential Hypertension, run by Novartis Pharmaceuticals at 8 sites in Turkey (Türkiye).

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 population that will be included in this study, will be regular Turkish hypertensive patients who are expected to consume sodium in high amounts. It is hypothesized that, in that population, amlodipine/valsartan will be effective at the same rate of blood pressure (BP) control rate as expected from literature. Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Essential Hypertension
What is being tested?: amlodipine/valsartan
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 115 participants
Where: 8 sitesTurkey (Türkiye)
Study dates: Feb 2014to Sep 2015
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 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Male or female, above 18 years of age
Diagnosis of essential hypertension
Newly diagnosed,
Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
Written informed consent

Who cannot join

Known or suspected secondary hypertension
eGFR lower than 30 mL/min
Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Use of other investigational drugs within 5 half-lives of enrollment, or within 30 days until the expected PD effect has returned to baseline, whichever is longer.Pregnant or nursing (lactating) women
Other protocol-defined inclusion/exclusion criteria may apply.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

Turkey (Türkiye)8 sites

Novartis Investigative Site
Ankara, 06100
Novartis Investigative Site
Çanakkale
Novartis Investigative Site
Fatih / Istanbul, 34098
Novartis Investigative Site
Kinikli / Denizli, 20070
Novartis Investigative Site
Kocaeli, 41380
Novartis Investigative Site
Malatya, 44280
Novartis Investigative Site
Mersin, 33079
Novartis Investigative Site
Talas / Kayseri, 38039

Other trials in Turkey (Türkiye)

About this study

Official title: A Single-Arm Open-Label Multicenter Phase IV Clinical Trial to Explore the Blood Pressure Lowering Effect of Exforge® (Amlodipine/Valsartan: AMLO/VAL) in Hypertensive Patients

Conditions: Essential Hypertension
Being tested: amlodipine/valsartan
Keywords: essential hypertension
Medical subject headings: Essential Hypertension

What participants receive

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

amlodipine/valsartanDrug
Fixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg

Study groups in NCT02062645
Study group	Role	What they receive
amlodipine/valsartan	Experimental	All patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks. Receives: Drug: amlodipine/valsartan

What is being measured

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

Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Control rate of BP defined as BP lower than 140/90 mmHg at office visits
Measured: At week 4 and 8

Secondary outcomes (4)

Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Change in systolic blood pressure measured in office from baseline at week 4 and 8.
Measured: baseline, week 4, week 8
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Change in diastolic blood pressure measured in office from baseline at week 4 and week 8.
Measured: baseline, week 4, week 8
Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Control rate of BP is defined as blood pressure lower than 140/90 mmHg at office visits in patients with high sodium intake (>100 mEq/day)
Measured: At week 4 and 8
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
Change in systolic and diastolic blood pressure measured in office from baseline at week 4 and 8.
Measured: At week 4 and 8

Timeline

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

Feb 2014Sep 2015

First posted14 Feb 2014 (estimated)
Study startFeb 2014
Primary completionSep 2015
Study completionSep 2015

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.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 115 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02062645
Sponsor's protocol ID: CVAA489ATR04
Status last verified: Feb 2017
First submitted: 12 Feb 2014
Last updated: 28 Mar 2017
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?

See locations

Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
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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
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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
Pregnancy-Associated Hypertension, Gestational Hypertension

All Essential Hypertension trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Single-Arm Open-Label Multicenter Phase IV Clinical Trial to Explore the Blood Pressure Lowering Effect of Exforge® (Amlodipine/Valsartan: AMLO/VAL) in Hypertensive Patients
ClinicalTrials.gov ID: NCT02062645
Acronym / sponsor ID: CVAA489ATR04
Conditions: Essential Hypertension
Keywords: essential hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 115 participants (actual)
Lead sponsor: Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: Feb 2014
Primary completion: Sep 2015 (actual)
Study completion: Sep 2015 (actual)
First posted: 14 Feb 2014 (estimated)
Results: Posted 28 Mar 2017

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
amlodipine/valsartan	Experimental	Drug: amlodipine/valsartanAll patients will receive amlodipine/valsartan 5/160 mg daily in screening and up titrated to amlodipine/valsartan 10/160 mg daily at visit 2 (day 30) if their hypertension can not be controlled. The duration of treatment period is 8 weeks.

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Male or female, above 18 years of age
Diagnosis of essential hypertension
Newly diagnosed,
Previously untreated, or Currently untreated (not on regular antihypertensive treatment during the previous at least 1-month period)
Written informed consent

Key exclusion criteria (7 listed)

Known or suspected secondary hypertension
eGFR lower than 30 mL/min
Use of any other hypertension treatments during the enrollment and need for using the related treatments during the study phase
History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes. (i.e. valsartan, amlodipine, hydrochlorothiazide)
History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.

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
amlodipine/valsartanFixed combination of amlodipine and valsartan in tablet; 5/160/mg, 10/160 mg	Drug	amlodipine/valsartan

Primary outcome

Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Time frame: At week 4 and 8
Control rate of BP defined as BP lower than 140/90 mmHg at office visits

4 secondary outcomes

Systolic Blood Pressure (SBP) at Baseline, Week 4 and 8
Time frame: baseline, week 4, week 8
Diastolic Blood Pressure (DBP) at Baseline, Week 4 and 8
Time frame: baseline, week 4, week 8
Percentage of Participants With High Sodium Intake and Blood Pressure (BP) <140/90 mmHg at Week 4 and 8
Time frame: At week 4 and 8
SBP and DBP in Patients With High Sodium Intake at Week 4 and 8
Time frame: At week 4 and 8

Results and safety

Results posted to the registry on 28 Mar 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Amlodipine/Valsartan	115	100

Primary outcome: Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8

Time frame: At week 4 and 8. Number. Unit: Percentage of Participants

Measure	Amlodipine/Valsartan n = 100
Week 4 Systolic (n=100)	47.0
Week 4 Diastolic (n=100)	78.0
Week 4 Overall Blood Pressure(n=100)	45.0
Week 8 Systolic(n=91)	70.3
Week 8 Diastolic (n=91)	82.4
Week 8 Overall Blood Pressure (n=91)	67.0
Week 8 Systolic (LOCF) (n=100)	68.0
Week 8 Diastolic (LOCF) (n=100)	81.0

Population analysed: The ITT (intent to treat) population defined as: met all entry criteria, received study drug and had at least one blood pressure measurement after Visit 1 (Day 0). One hundred patients had BP measurements at Visit 2 and 91 patients at Visit 3. LOCF (Visit 2 to Visit 3). Analysis performed both with original and imputed values

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Amlodipine/Valsartan	3 of 110 (2.7%)	76 of 110 (69.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2017.
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
Pregnancy-Associated Hypertension, Gestational Hypertension

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

8 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 amlodipine/valsartan in people with Essential Hypertension, run by Novartis Pharmaceuticals at 8 sites in Turkey (Türkiye).

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 7 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 28 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Turkey (Türkiye). 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 28 Mar 2017). 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?

Percentage of Participants With Blood Pressure (BP) <140/90 mmHg at Week 4 and 8 (time frame: At week 4 and 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 NCT02062645.

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 28 Mar 2017.