A Phase 4 interventional study of Nebivolol and Metoprolol ER in Hypertension and Type 2 Diabetes Mellitus, sponsored by Forest Laboratories. Completed at 65 sites in 2 countries. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2011-07-29.
Sponsored by Forest Laboratories · Phase 4, Interventional, and Treatment
This study will evaluate the effects of nebivolol on glycemic control compared with metoprolol and HCTZ in patients with hypertension and type 2 diabetes mellitus
6,689 studies on the registry are indexed under Hypertension; 965 are open to participants now.
This study's enrollment of 231 is above the median of 90 across 4,995 interventional studies indexed under Hypertension.
Browse Hypertension studies →Forest Laboratories is the lead sponsor of 165 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.
Counted across the registry records on this site, refreshed daily.
EXCLUSION CRITERIA:
* Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration * Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration * Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration * Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration * Open-label amlodipine may be given
Drug: Nebivolol
* Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration * Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration * Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration * Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration * Open-label amlodipine may be given
Drug: Metoprolol ER
* HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration * HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration * Open-label amlodipine may be given
Drug: HCTZ
* Nebivolol 5 mg (overencapsulated 5-mg marketed tablet), oral administration * Nebivolol 10 mg (overencapsulated 10-mg marketed tablet), oral administration * Nebivolol 20 mg (overencapsulated 20-mg marketed tablet) oral administration * Nebivolol 40 mg (two overencapsulated 20-mg tablets) oral administration
Also known as: Bystolic (TM)
* Metoprolol ER 50 mg (overencapsulated 50-mg tablet) oral administration * Metoprolol ER 100 mg (two overencapsulated 50-mg tablets) oral administration * Metoprolol ER 200 mg (overencapsulated 200-mg tablet) oral administration * Metoprolol ER 400 mg (two overencapsulated 200-mg tablets) oral administration
* HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration * HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Also known as: Hydrochlorothorazide
Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26
Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.
Time frame: visit 5(week 0) and visit 14(week 26)
Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR)
Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5
Time frame: [visit 5(week 0) and visit 14(week 26)]
Recruitment occured from September 2008 through December 2009 at 69 US sites
| Milestone | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) |
|---|---|---|---|
| Started | 83 | 73 | 74 |
| Completed | 56 | 46 | 59 |
| Not completed | 27 | 27 | 15 |
| Withdrew: Lack of efficacy | 1 | 1 | 0 |
| Withdrew: Withdrawal by subject | 9 | 5 | 3 |
| Withdrew: Lost to follow-up | 1 | 1 | 1 |
| Withdrew: Protocol violation | 3 | 4 | 3 |
| Withdrew: Inclusion/exclusion criteria not met | 1 | 0 | 0 |
| Withdrew: Dosing error | 1 | 0 | 1 |
| Withdrew: Study drug error | 1 | 0 | 0 |
| Withdrew: Prohibited concomitant medication | 0 | 0 | 1 |
| Withdrew: Poor compliance | 0 | 2 | 0 |
| Withdrew: Administrative. site closed | 1 | 1 | 1 |
| Withdrew: Adverse event | 9 | 13 | 5 |
Change from baseline in glycosylated hemoglobin (HbA1c) over 26 weeks, Last Observation Carried Forward.
| Percentage | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) |
|---|---|---|---|
| Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 | 0.12 ± 0.78 | 0.00 ± 0.65 | 0.40 ± 0.96 |
Change from Baseline in Insulin Resistance based on homeostasis model assessment of insulin resistance (HOMA-IR) at week 26, Last Observation Carried Forward (LOCF). The HOMA-IR is the the product of the blood Glucose and Insulin levels, divided by a constant. HOMA-IR is expressed as the following: HOMA-IR = fasting serum insulin (μU/ml) × fasting plasma glucose (mmol/l) / 22.5
| Unit on a scale | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) |
|---|---|---|---|
| Change From Baseline in Insulin Resistance Based on Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) | 0.011 ± 9.828 | 1.156 ± 9.628 | -0.662 ± 10.178 |
Collected over Adverse Events were reported over a 12-month period, from September 2008 to August 2010.. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nebivolol | — | 2/83 (2.4%) | 19/83 (22.9%) |
| Metoprolol ER | — | 3/73 (4.1%) | 17/73 (23.3%) |
| Hydrochlorothiazide (HCTZ) | — | 2/74 (2.7%) | 17/74 (23%) |
| Event | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) |
|---|---|---|---|
| CardiomegalyCardiac disorders | 0/83 | 1/73 | 0/74 |
| Deep vain thrombosis postoperativeInjury, poisoning and procedural complications | 0/83 | 1/73 | 0/74 |
| Incision site cellulitisInfections and infestations | 0/83 | 1/73 | 0/74 |
| Intervertebral disc degenerationMusculoskeletal and connective tissue disorders | 0/83 | 1/73 | 0/74 |
| OsteoarthritisMusculoskeletal and connective tissue disorders | 0/83 | 1/73 | 0/74 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 0/83 | 1/73 | 0/74 |
| Spinal column stenosisMusculoskeletal and connective tissue disorders | 0/83 | 1/73 | 0/74 |
| Abdominal painGastrointestinal disorders | 0/83 | 0/73 | 1/74 |
| Breast cancer metastaticNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 0/83 | 0/73 | 1/74 |
| ArrhythmiaCardiac disorders | 1/83 | 0/73 | 0/74 |
| Event | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) |
|---|---|---|---|
| BradycardiaCardiac disorders | 6/83 | 8/73 | 0/74 |
| Oedema peripheralGeneral disorders | 8/83 | 7/73 | 6/74 |
| HeadacheNervous system disorders | 5/83 | 7/73 | 5/74 |
| CoughRespiratory, thoracic and mediastinal disorders | 3/83 | 6/73 | 1/74 |
| FatigueGeneral disorders | 3/83 | 1/73 | 5/74 |
| HyperglycaemiaMetabolism and nutrition disorders | 1/83 | 1/73 | 5/74 |
| Upper Resiratory tract infectionInfections and infestations | 2/83 | 1/73 | 5/74 |
| DizzinessNervous system disorders | 5/83 | 3/73 | 3/74 |
| NasopharyngitisInfections and infestations | 2/83 | 4/73 | 3/74 |
| Age Continuous(years) | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) | Total |
|---|---|---|---|---|
| Mean | 58.2 ± 9.3 | 59.2 ± 8.3 | 59.5 ± 9.0 | 58.9 ± 8.9 |
| Age, Customized(participants) | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) | Total |
|---|---|---|---|---|
| Patients 18 to 64 years of age | 61 | 51 | 53 | 165 |
| Patients greater than or equal to 65 years of age. | 22 | 22 | 21 | 65 |
| Sex: Female, Male(Participants) | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) | Total |
|---|---|---|---|---|
| Female | 30 | 30 | 29 | 89 |
| Male | 53 | 43 | 45 | 141 |
| Region of Enrollment(participants) | Nebivolol | Metoprolol ER | Hydrochlorothiazide (HCTZ) | Total |
|---|---|---|---|---|
| United States | 78 | 69 | 72 | 219 |
| Puerto Rico | 5 | 4 | 2 | 11 |
This study is completed, as verified in Jun 2011. You cannot join it, but the record below documents what was studied.
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Forest Laboratories