A Phase 4 interventional study of Nebivolol with concomitant losartan or lisinopril and HCTZ with concomitant losartan or lisinopril in Hypertension, sponsored by Forest Laboratories. Completed at 88 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Forest Laboratories (part of AbbVie) · Phase 4, Interventional, and Treatment
This study is being done to see if the blood pressure and metabolic effects of an approved drug nebivolol is comparable to that of another approved drug hydrochlorothiazide (HCTZ) and placebo in hypertensive patients.
This study is double blind (neither you nor the physician will know when you are receiving placebo, which is an inactive compound such as a sugar pill, or active study drugs nebivolol or hydrochlorothiazide).
All participants will also receive lisinopril, an angiotensin converting enzyme, or losartan, an angiotensin receptor blocker. All medications are approved and marketed for the treatment of hypertension.This study is being conducted in about 500 patients at approximately 80 research centers in the United States.
The study consists of approximately 9 study visits over a period of 5 months. During these visits, patients will undergo routine health exams and some special laboratory tests such as an oral glucose tolerance test.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 537 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Forest Laboratories is the lead sponsor of 168 studies on the registry; none are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 6 (100%) have results posted.
First submitted before Forest Laboratories became part of AbbVie.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Nebivolol with concomitant losartan or lisinopril
Drug: Nebivolol with concomitant losartan or lisinopril
HCTZ with concomitant losartan or lisinopril
Drug: HCTZ with concomitant losartan or lisinopril
Placebo with concomitant losartan or lisinopril
Drug: Placebo with concomitant losartan or lisinopril
Encapsulated Nebivolol 5 mg, 10 mg, 20, mg, 40 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Encapsulated Hydrochlorothiazide 12.5 mg or 25 mg total daily dosage, oral administration with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Placebo with concomitant treatment consisting of lisinopril 10 mg total daily dosage, oral administration or losartan 50 mg total daily dosage, oral administration.
Trough Seated Diastolic Blood Pressure
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
Time frame: Change from Baseline Visit 4 (Week 0) To Visit 8 (Week 12)
Plasma Glucose Level After an Oral Glucose Tolerance Test
Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.
Time frame: Change from Baseline Visit 3 or 4 (Week -2 or 0) To Visit 8 (Week 12)
May 2008 to March 2010 at 96 US sites, 72 sites randomized patients.
| Milestone | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo |
|---|---|---|---|
| Started | 223 | 212 | 102 |
| Completed | 178 | 174 | 90 |
| Not completed | 45 | 38 | 12 |
| Withdrew: Adverse event | 23 | 14 | 2 |
| Withdrew: Lack of efficacy | 2 | 2 | 2 |
| Withdrew: Protocol violation | 6 | 9 | 1 |
| Withdrew: Withdrawal by subject | 7 | 4 | 1 |
| Withdrew: Lost to follow-up | 6 | 6 | 5 |
| Withdrew: Sponsor terminated due to pi oversight | 0 | 1 | 0 |
| Withdrew: Poor compliance | 1 | 0 | 0 |
| Withdrew: Participated in two nebivolol studies | 0 | 0 | 1 |
| Withdrew: Unconfirmed pregnancy | 0 | 1 | 0 |
| Withdrew: Randomization criteria not met | 0 | 1 | 0 |
Change from Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) at Week 12, Last Observation Carried Forward (LOCF).
| mm Hg | Nebivolol | Placebo |
|---|---|---|
| Trough Seated Diastolic Blood Pressure | -9.4 ± 8.9 | -5.0 ± 9.5 |
Change from Baseline in Plasma Glucose 2 Hours Post-oral Glucose 75 grams, given as part of an Oral Glucose Tolerance Test (OGTT). Last Observation Carried Forward.
| g/mL | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo |
|---|---|---|---|
| Plasma Glucose Level After an Oral Glucose Tolerance Test | 0.20 ± 0.190 | 0.31 ± 0.184 | -0.21 ± 0.247 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebivolol | — | 5/223 (2.2%) | 35/223 (15.7%) |
| Hydrochlorothiazide (HCTZ) | — | 6/212 (2.8%) | 21/212 (9.9%) |
| Placebo | — | 2/102 (2%) | 14/102 (13.7%) |
| Event | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo |
|---|---|---|---|
| FallInjury, poisoning and procedural complications | 0/223 | 0/212 | 1/102 |
| Humerus fractureInjury, poisoning and procedural complications | 0/223 | 0/212 | 1/102 |
| MigraineNervous system disorders | 0/223 | 0/212 | 1/102 |
| Myocardial infactionCardiac disorders | 0/223 | 2/212 | 0/102 |
| AngioedemaSkin and subcutaneous tissue disorders | 0/223 | 1/212 | 0/102 |
| Cardiac arrestCardiac disorders | 0/223 | 1/212 | 0/102 |
| Chest painGeneral disorders | 0/223 | 1/212 | 0/102 |
| DepressionPsychiatric disorders | 0/223 | 1/212 | 0/102 |
| Oesophageal stenosisGastrointestinal disorders | 0/223 | 1/212 | 0/102 |
| OesophagitisGastrointestinal disorders | 0/223 | 1/212 | 0/102 |
| Event | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo |
|---|---|---|---|
| HeadacheNervous system disorders | 12/223 | 12/212 | 7/102 |
| Upper respiratory tract infectionInfections and infestations | 12/223 | 10/212 | 7/102 |
| BradycardiaCardiac disorders | 12/223 | 0/212 | 0/102 |
| Age, Continuous(years) | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo | Total |
|---|---|---|---|---|
| Mean | 54.4 ± 9.6 | 55.7 ± 10.4 | 55.2 ± 11.3 | 55.1 ± 10.3 |
| Age, Customized(Participants) | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo | Total |
|---|---|---|---|---|
| Patients 18 to 65 years of age | 190 | 172 | 81 | 443 |
| Patients greater than or equal to 65 years of age. | 33 | 40 | 21 | 94 |
| Sex: Female, Male(Participants) | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo | Total |
|---|---|---|---|---|
| Female | 101 | 97 | 38 | 236 |
| Male | 122 | 115 | 64 | 301 |
| Region of Enrollment(Participants) | Nebivolol | Hydrochlorothiazide (HCTZ) | Placebo | Total |
|---|---|---|---|---|
| United States | 223 | 212 | 102 | 537 |
Ran from May 2008 to primary completion in Jul 2010, 25 months.
Results were first posted in Feb 2020, 9 years 7 months after primary completion.
Of 35 industry-sponsored phase 4 interventional studies under Hypertension, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 31. This study's 25 months is above that.
Counting every sponsor, half of 161 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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