JNC 7 Stage 1 or 2 HypertensionPhase 4NCT03635125
Efficacy and Safety of Nebivolol Versus Metoprolol in Hypertensive Subject Taking Amlodipine
A Phase 4 study testing Nebivolol I, Nebivolol II and Baseline Washout Phase in people with JNC 7 Stage 1 or 2 Hypertension, run by Trinity Hypertension & Metabolic Research Institute at 1 site in United States.
Trial summary
Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- JNC 7 Stage 1 or 2 Hypertension
- What is being tested?
- Nebivolol I, Nebivolol II and Baseline Washout Phase
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2010to 18 Jul 2011
- 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
- No healthy volunteers
- 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 equal/over 18 years of age.
- Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 95 mmHg and equal/less 115 mmHg and Systolic blood pressure equal/less to 180 mmHg at two consecutive qualifying visits during the placebo run in period.
- Arm circumference less 45 cm
- Compliance with single blind placebo capsules between V1-4 of 80-120%.
- Women may be enrolled if all three of the following criteria are met:
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- Have a negative serum pregnancy test at screening
- Are not breastfeeding
- Do not plan to become pregnant during the study and if one of the three criteria is met:
- Have had a hysterectomy or tubal ligation at least 6 months prior to signing the informed consent form
- Have been postmenopausal for at least 1 year
- Are of childbearing potential and will practice one 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.
Who cannot join
- Known allergy or hypersensitivity to Beta Blockers.
- Known allergy or hypersensitivity to Calcium Channel Blockers.
- Patients with severe hypertension (mean seated cuff Diastolic blood pressure > 115 mmHg or mean seated Systolic blood pressure >180 mmHg) 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 trans luminal 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 hypoglycemic 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 investigation 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 sever asthma or Chronic obstructive pulmonary disease.
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Randomized, Open-Label, Active-Comparator, Blinded-Endpoint, 12-week Forced-Titration Study of the Efficacy and Safety of Nebivolol Verses Metoprolol in Hypertensive Subjects Taking Amlodipine
Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.
Read the detailed description
Open-label, single center study consisting of a 2 to 4 week baseline washout phase, a 12-week Amlodipine background treatment phase followed by a 4-week Low Dose Nebivolol/Metoprolol Treatment phase and a 4-week High Dose Nebivolol/Metoprolol Treatment Phase.
- Conditions
- JNC 7 Stage 1 or 2 Hypertension
- Being tested
- Nebivolol I, Nebivolol II, Baseline Washout Phase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nebivolol IDrug
Also called Metoprolol I
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg
Nebivolol IIDrug
Also called Metoprolol II
Low dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg
Baseline Washout PhaseOther
2 to 4 week Baseline Washout Phase
| Study group | Role | What they receive |
|---|---|---|
| Background treatment phase | No intervention | A 12- week Amlodipine 10 mg background treatment phase |
| Low Dose Treatment Phase-Nebivolol I | Active comparator | 4-week low dose Nebivolol10 mg/Metoprolol 50 mg treatment phase Receives: Drug: Nebivolol I; Drug: Nebivolol II |
| High dose treatment Phase-Nebivolol II | Active comparator | 4-week High dose Nebivolol 20 mg/Metoprolol 100mg treatment phase Receives: Drug: Nebivolol I; Drug: Nebivolol II |
| Baseline Washout Phase | Other | 2 to 4 week Baseline Washout Phase Receives: Other: Baseline Washout Phase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change from baseline in trough Diastolic Blood Pressure
Mean change by millimeters of mercury from baseline in trough Diastolic Blood Pressure
Measured: 4 and 8 weeks of treatment
Mean Change in Edema Measurement
Mean change in edema measurement by water immersion of treatment in millimeters of water
Measured: 4 and 8 weeks of treatment
Secondary outcomes (2)
Change from baseline in trough Systolic blood pressure of treatment.
Change from baseline by millimeters of mercury in trough Systolic blood pressure of treatment.
Measured: 4 and 8 weeks of treatment
Percentage of subjects achieving Blood pressure goals
Percentage of subjects achieving Blood pressure goals of either Nebivolol compared to Metoprolol
Measured: 4 and 8 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start30 Aug 2010
- Primary completion26 May 2011
- Study completion18 Jul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for JNC 7 Stage 1 or 2 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 4
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 12-week Amlodipine background treatment phase followed by a 4-week Low dose Nebivolol/Metoprolol treatment phase and a 4-week high dose Nebivolol/Metoprolol treatment phase
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Hypertension & Metabolic Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henry A Punzi, MD, Principal investigator, Punzi Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635125
- Sponsor's protocol ID
- BYS-MD-48
- Status last verified
- Aug 2018
- First submitted
- 15 Mar 2018
- Last updated
- 20 Aug 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 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open-Label, Active-Comparator, Blinded-Endpoint, 12-week Forced-Titration Study of the Efficacy and Safety of Nebivolol Verses Metoprolol in Hypertensive Subjects Taking Amlodipine
- ClinicalTrials.gov ID
- NCT03635125
- Acronym / sponsor ID
- BYS-MD-48
- Conditions
- JNC 7 Stage 1 or 2 Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Trinity Hypertension & Metabolic Research InstituteUniversity, hospital or other
- Study start
- 30 Aug 2010 (actual)
- Primary completion
- 26 May 2011 (actual)
- Study completion
- 18 Jul 2011 (actual)
- First posted
- 17 Aug 2018 (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.
Study is to evaluate the effect of Nebivolol to treat high blood pressure compared to an already approved drug, Metoprolol ER with background treatment of Amlodipine.
Detailed description
Open-label, single center study consisting of a 2 to 4 week baseline washout phase, a 12-week Amlodipine background treatment phase followed by a 4-week Low Dose Nebivolol/Metoprolol Treatment phase and a 4-week High Dose Nebivolol/Metoprolol Treatment Phase.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- 12-week Amlodipine background treatment phase followed by a 4-week Low dose Nebivolol/Metoprolol treatment phase and a 4-week high dose Nebivolol/Metoprolol treatment phase
| Arm | Type | Receives |
|---|---|---|
| Background treatment phase | No intervention | –A 12- week Amlodipine 10 mg background treatment phase |
| Low Dose Treatment Phase-Nebivolol I | Active comparator | Drug: Nebivolol I, Drug: Nebivolol II4-week low dose Nebivolol10 mg/Metoprolol 50 mg treatment phase |
| High dose treatment Phase-Nebivolol II | Active comparator | Drug: Nebivolol I, Drug: Nebivolol II4-week High dose Nebivolol 20 mg/Metoprolol 100mg treatment phase |
| Baseline Washout Phase | Other | Other: Baseline Washout Phase2 to 4 week Baseline Washout Phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Capable of reading, comprehending the consent process and providing written informed consent to participate in the study.
- Male or female equal/over 18 years of age.
- Stage I-II hypertension defined as a baseline mean seated cuff Diastolic blood pressure of equal/over 95 mmHg and equal/less 115 mmHg and Systolic blood pressure equal/less to 180 mmHg at two consecutive qualifying visits during the placebo run in period.
- Arm circumference less 45 cm
- Compliance with single blind placebo capsules between V1-4 of 80-120%.
Key exclusion criteria (20 listed)
- Known allergy or hypersensitivity to Beta Blockers.
- Known allergy or hypersensitivity to Calcium Channel Blockers.
- Patients with severe hypertension (mean seated cuff Diastolic blood pressure > 115 mmHg or mean seated Systolic blood pressure >180 mmHg) 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 trans luminal 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 |
|---|---|---|
| Nebivolol IAlso: Metoprolol ILow dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20 mg or Metoprolol 100mg | Drug | High dose treatment Phase-Nebivolol II, Low Dose Treatment Phase-Nebivolol I |
| Nebivolol IIAlso: Metoprolol IILow dose treatment phase: Nebivolol 10 mg or Metoprolol 50 mg High dose treatment phase: Nebivolol 20mg or Metoprolol 100mg | Drug | High dose treatment Phase-Nebivolol II, Low Dose Treatment Phase-Nebivolol I |
| Baseline Washout Phase2 to 4 week Baseline Washout Phase | Other | Baseline Washout Phase |
Primary outcome
Mean Change from baseline in trough Diastolic Blood Pressure
Time frame: 4 and 8 weeks of treatment
Mean change by millimeters of mercury from baseline in trough Diastolic Blood Pressure
Mean Change in Edema Measurement
Time frame: 4 and 8 weeks of treatment
Mean change in edema measurement by water immersion of treatment in millimeters of water
2 secondary outcomes
Change from baseline in trough Systolic blood pressure of treatment.
Time frame: 4 and 8 weeks of treatment
Percentage of subjects achieving Blood pressure goals
Time frame: 4 and 8 weeks of treatment
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 20 Aug 2018.
- Individual participant dataSharing planned: No
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
Punzi 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 Nebivolol I, Nebivolol II and Baseline Washout Phase in people with JNC 7 Stage 1 or 2 Hypertension, 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 12 inclusion and 20 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 20 Aug 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?
Mean Change from baseline in trough Diastolic Blood Pressure (time frame: 4 and 8 weeks of treatment). 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 20 Aug 2018.