Hypertension ComplicatedPhase 4BVreduceNCT03180593
Efficacy and Safety of Valsartan and Nebivolol/Valsartan in Hypertensive Patients With LVH
A Phase 4 study testing Valsartan 80 mg in people with Hypertension Complicated and Hypertrophy, Left Ventricular, run by Trinity Hypertension & Metabolic Research Institute at 1 site in United States.
Trial summary
To assess the efficacy of Left Ventricular Hypertrophy (LVH) reduction and 24-hour blood pressure control of Valsartan 80mg or Nebivolol/Valsartan 5/80mg once daily as replacement therapy for currently treated or untreated hypertensive patients with LVH not at BP goal. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension Complicated, Hypertrophy, Left Ventricular, Blood Pressure
- What is being tested?
- Valsartan 80 mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 25 Jan 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Capable of reading, comprehending the consent process and providing written informed consent to participate in the study.
- Male or female ≥ 18 years of age who are either newly diagnosed with HTN or who are currently being treated.
- Patients must have a mean cuff sitting diastolic blood pressure cuff (DBP) > 90 mmHg and <105 mmHg (< 100 mmHg on prior treatment) and mean cuff sitting systolic blood pressure (SBP) <160 mmHg, at two consecutive qualifying visits during the placebo run in period.
- Arm circumference < 45cm.
- Compliance with single blind placebo capsules between V1 to 4 or 4X of 80-120%.
- Women may be enrolled if the following criteria are met:
- 1.- Have a negative serum pregnancy test at screening 2.- Are not breastfeeding 3.- Do not plan to become pregnant during the study 4.- Have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form or 5.- Have been postmenopausal for at least 1 year or 6. - If they are of childbearing potential and will practice one of the following methods of birth control throughout the study: oral, patch, injectable, or implantable hormone contraception, intrauterine device, diaphragm plus spermicide or female condom plus spermicide. Abstinence, partner's vasectomy are not acceptable methods of contraception.
- 7. Diagnosis of Left Ventricular Hypertrophy (LVH).
Who cannot join
- Known allergy or hypersensitivity to Beta-Blockers.
- Known allergy or hypersensitivity to Angiotensin II Receptor Blockers.
- Patients with severe hypertension (mean seated cuff DBP>115 mmHg or mean seated SBP> 180mmHg) or any form of secondary hypertension.
- Patients within the past 6 months with a history of hypertensive encephalopathy, stroke or transient ischemic attack.
- Patients within the last 6 months with a history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
- Patients with evidence of resting bradycardia (<50 bpm) via palpation.
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- Patients with a history of heart block greater than First Degree Sino-atrial Block. Wolff-Parkinson-White Syndrome, Sick Sinus Syndrome, Atrial Fibrillation, Atrial Flutter, Congestive Heart Failure, or other manifestations of clinically significant cardiac valvular disease.
- Patients with hemodynamically significant cardiac valvular disease.
- Patients with evidence of significant chronic renal impairment as indicated by a serum creatinine of > 2.5mg/dL.
- Patients with evidence of liver disease as indicated by AST (SGOT) or ALT (SGPT) > 2.5 times or total bilirubin > 1.5 times, the upper limit of the laboratory normal range.
- Patients who demonstrate other laboratory test values deviating from the normal range which are considered to be clinically significant by the investigator.
- Patient with a history or presence of gastrointestinal disease which may interfere with drug absorption.
- Patients with insulin and non-insulin dependent diabetes mellitus not controlled on diet, insulin, or oral hypoglycemics as defined by a HgA1c >10.
- Severe psychological or emotional condition which may interfere with participation in the study.
- History of or current use of illicit drugs or alcohol abuse.
- Participation in a clinical trial and taking any investigational drug within 30 days prior to enrolling into the study (Screening Visit).
- A physical condition that would limit accurate BP measurement.
- Inability to swallow a tablet or capsule.
- History of moderate or severe asthma or COPD.
- Any other medical condition which, in the Investigator's opinion, may render the patient unable to complete the study or which would interfere with optimal participation in the study or produce significant risk to the patient.
- Patients taking more than two blood pressure medications
- Patients currently taking a beta blocker
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
Trinity Hypertension & Metabolic Research Institute
Carrollton, Texas, 75006
About this study
Official title: A Prospective, Randomized, Open-Label, 13 to 14-week Study of the Efficacy and Safety of Valsartan and Nebivolol/Valsartan in Hypertensive Subjects With Left Ventricular Hypertrophy (LVH)
To assess the efficacy of Left Ventricular Hypertrophy (LVH) reduction and 24-hour blood pressure control of Valsartan 80mg or Nebivolol/Valsartan 5/80mg once daily as replacement therapy for currently treated or untreated hypertensive patients with LVH not at BP goal.
Read the detailed description
The potential benefits of blood pressure reduction have been demonstrated in numerous large clinical trials. The most recent is the SPRINT Trial demonstrating that lower blood pressure goals can be achieved and are associated with a significant decrease in morbidity and mortality. The latest NHANES 2012 data reveal that less than 50% of patients that are aware of the elevated blood pressure and are being treated achieve blood pressure control. Treatment of hypertension in many patients (>70%) require treatment with more than one drug, increasing the likelihood of non-compliance and not achieving blood pressure goal. JNC 8 recommends the utilizing of combination therapy both for Stage I and Stage II Hypertensive patients.
Objectives of the study to assess the efficacy of LVH reduction and 24-hour blood pressure control of Valsartan 80mg and Nebivolol/Valsartan 5/80mg, once daily for the treatment of currently treated hypertensive patients with LVH.
The study will evaluate LVH reduction at 4 and 8 weeks as well as change from baseline in mean 24 hour ABPM SBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg
- Being tested
- Valsartan 80 mg
- Medical subject headings
- Hypertrophy, Left Ventricular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valsartan 80 mgDrug
Also called Nebivolol/Valsartan 5/80mg
Compare office and 24-hour Blood Pressure Control and regression of Left Ventricular Hypertrophy
| Study group | Role | What they receive |
|---|---|---|
| Valsartan Arm | Active comparator | Valsartan 80mg randomly assigned for 8 weeks to asses BP control with office and 24-hour ABPM and reduction of LVH Receives: Drug: Valsartan 80 mg |
| Nebivolol/Valsartan | Active comparator | Nebivolol/Valsartan 5/80mg randomly assigned for 8 weeks to asses Blood Pressure control with office and 24-hour Ambulatory Blood Pressure Monitoring and reduction of Left Ventricular Hypertrophy Receives: Drug: Valsartan 80 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
LVH reduction at 4 weeks.
Reduction of Left ventricular hypertrophy from baseline compared to 4 weeks of treatment
Measured: 4 weeks
24hr-ABPM measurement Change from baseline in mean 24 hour ABPM SBP
Reduction of Systolic BP over 24 hours baseline compared to 4 weeks of treatment
Measured: 4 weeks
Secondary outcomes (4)
LVH reduction at 8 weeks.
Reduction of Left ventricular hypertrophy from baseline compared to 8 weeks of treatment
Measured: 8 weeks
24hr-Systolic ABPM measurement
Reduction of Systolic BP over 24 hours baseline compared to 8 weeks of treatment
Measured: 8 weeks
24hr- DBP ABPM measurements
Mean change from baseline in trough DBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg
Measured: 4 and 8 weeks
Office Blood Pressure measurements
Mean change from baseline in trough SBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg
Measured: 4 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2017
- Study start7 Feb 2017
- Primary completion25 Jan 2018
- Study completion25 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension ComplicatedStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, randomized, open label, blinded-endpoint (PROBE)
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Hypertension & Metabolic Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Allergan Sales, LLC
- Responsible party
- Principal investigator, Henry Anthony Punzi, Trinity Hypertension & Metabolic Research Institute
- Investigators
- Henry A Punzi, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03180593
- Sponsor's protocol ID
- BYS-IT-78
- Acronym
- BVreduce
- Status last verified
- Apr 2018
- First submitted
- 6 Jun 2017
- Last updated
- 11 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, 13 to 14-week Study of the Efficacy and Safety of Valsartan and Nebivolol/Valsartan in Hypertensive Subjects With Left Ventricular Hypertrophy (LVH)
- ClinicalTrials.gov ID
- NCT03180593
- Acronym / sponsor ID
- BVreduce / BYS-IT-78
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Trinity Hypertension & Metabolic Research InstituteUniversity, hospital or other
- Collaborators
- Allergan Sales, LLC
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 25 Jan 2018 (actual)
- Study completion
- 25 Jan 2018 (actual)
- First posted
- 8 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of Left Ventricular Hypertrophy (LVH) reduction and 24-hour blood pressure control of Valsartan 80mg or Nebivolol/Valsartan 5/80mg once daily as replacement therapy for currently treated or untreated hypertensive patients with LVH not at BP goal.
Detailed description
The potential benefits of blood pressure reduction have been demonstrated in numerous large clinical trials. The most recent is the SPRINT Trial demonstrating that lower blood pressure goals can be achieved and are associated with a significant decrease in morbidity and mortality. The latest NHANES 2012 data reveal that less than 50% of patients that are aware of the elevated blood pressure and are being treated achieve blood pressure control. Treatment of hypertension in many patients (>70%) require treatment with more than one drug, increasing the likelihood of non-compliance and not achieving blood pressure goal. JNC 8 recommends the utilizing of combination therapy both for Stage I and Stage II Hypertensive patients.
Objectives of the study to assess the efficacy of LVH reduction and 24-hour blood pressure control of Valsartan 80mg and Nebivolol/Valsartan 5/80mg, once daily for the treatment of currently treated hypertensive patients with LVH.
The study will evaluate LVH reduction at 4 and 8 weeks as well as change from baseline in mean 24 hour ABPM SBP after 4 and 8 weeks of treatment with valsartan 80mg or nebivolol/valsartan 5/80mg
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Prospective, randomized, open label, blinded-endpoint (PROBE)
| Arm | Type | Receives |
|---|---|---|
| Valsartan Arm | Active comparator | Drug: Valsartan 80 mgValsartan 80mg randomly assigned for 8 weeks to asses BP control with office and 24-hour ABPM and reduction of LVH |
| Nebivolol/Valsartan | Active comparator | Drug: Valsartan 80 mgNebivolol/Valsartan 5/80mg randomly assigned for 8 weeks to asses Blood Pressure control with office and 24-hour Ambulatory Blood Pressure Monitoring and reduction of Left Ventricular Hypertrophy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Capable of reading, comprehending the consent process and providing written informed consent to participate in the study.
- Male or female ≥ 18 years of age who are either newly diagnosed with HTN or who are currently being treated.
- Patients must have a mean cuff sitting diastolic blood pressure cuff (DBP) > 90 mmHg and <105 mmHg (< 100 mmHg on prior treatment) and mean cuff sitting systolic blood pressure (SBP) <160 mmHg, at two consecutive qualifying visits during the placebo run in period.
- Arm circumference < 45cm.
- Compliance with single blind placebo capsules between V1 to 4 or 4X of 80-120%.
Key exclusion criteria (23 listed)
- Known allergy or hypersensitivity to Beta-Blockers.
- Known allergy or hypersensitivity to Angiotensin II Receptor Blockers.
- Patients with severe hypertension (mean seated cuff DBP>115 mmHg or mean seated SBP> 180mmHg) or any form of secondary hypertension.
- Patients within the past 6 months with a history of hypertensive encephalopathy, stroke or transient ischemic attack.
- Patients within the last 6 months with a history of myocardial infarction, percutaneous transluminal coronary revascularization, coronary bypass graft, valvular surgery or unstable angina.
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 80 mgAlso: Nebivolol/Valsartan 5/80mgCompare office and 24-hour Blood Pressure Control and regression of Left Ventricular Hypertrophy | Drug | Nebivolol/Valsartan, Valsartan Arm |
Primary outcome
LVH reduction at 4 weeks.
Time frame: 4 weeks
Reduction of Left ventricular hypertrophy from baseline compared to 4 weeks of treatment
24hr-ABPM measurement Change from baseline in mean 24 hour ABPM SBP
Time frame: 4 weeks
Reduction of Systolic BP over 24 hours baseline compared to 4 weeks of treatment
4 secondary outcomes
LVH reduction at 8 weeks.
Time frame: 8 weeks
24hr-Systolic ABPM measurement
Time frame: 8 weeks
24hr- DBP ABPM measurements
Time frame: 4 and 8 weeks
Office Blood Pressure measurements
Time frame: 4 and 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2018.
- Individual participant dataSharing planned: No
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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.
Henry A Punzi, MD principal investigator
University of Texas Southwestern Medical Center
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 80 mg in people with Hypertension Complicated and Hypertrophy, Left Ventricular, run by Trinity Hypertension & Metabolic Research Institute 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 8 inclusion and 23 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 Apr 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
LVH reduction at 4 weeks. (time frame: 4 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Apr 2018.