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HypertensionPhase 4NCT00744237

Study of the Glycemic Effects of Nebivolol Compared With Metoprolol and HCTZ in Diabetic Hypertensive Patients

A Phase 4 study testing Nebivolol, Metoprolol ER and HCTZ in people with Hypertension and Type 2 Diabetes Mellitus, run by Forest Laboratories at 65 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Hypertension, Type 2 Diabetes Mellitus
What is being tested?
Nebivolol, Metoprolol ER and HCTZ
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
231 participants
Where
65 sitesin 2 countries
Study dates
Aug 2008to Jul 2010
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 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, 18-85 years of age
  • Blood pressure in the range of 130 to 179/80 to 109 mmHg
  • Currently using either an ACE inhibitor or an ARB alone or (an ACE inhibitor or an ARB and up to two other drugs for treatment of high blood pressure). (Patients may be on both an ACE inhibitor and ARB, but would need to be taken off one.)
  • Stable medication regimen for high blood pressure for at least one month prior to screening
  • Stable type 2 diabetes mellitus for at least 3 months prior to screening that is controlled by any or all of the following: diet and antidiabetic medications that may include fixed-dose insulin
  • HgbA1c 6.5 to 8.5% (This is measured at the screening visit)

Who cannot join

  • Use of any beta blocker within one month prior to screening
  • Use of clonidine within 3 months prior to screening
  • Diagnosis of hyperthyroidism as evidenced by abnormal lab markers
  • Any disorder requiring the intermittent or chronic use of systemic corticosteroids
  • Diagnosis of hyperthyroidism as determined by lab markers done at screening
  • Active liver disease as determined by lab markers
Show all 12Show fewer
  • Kidney impairment; estimated GFR < 60 mL/min/1.73 m2
  • History of heart attack, clinically significant arrhythmia, unstable angina, coronary angioplasty/bypass surgery, stroke, or TIA in 3 months prior to screening
  • Chronic heart failure
  • Drug or alcohol abuse within 2 years prior to screening
  • History of sensitivity to any beta blocker, HCTZ, sulfa drug, or calcium channel blocker
  • Participation in another research study within 30 days prior to screening

Trial locations and contacts

65 sites in 2 countries.

65 sites in 2 countries

United States62 sites

  • Forest Investigative Site 15

    Athens, Alabama, 35611

  • Forest Investigative Site 44

    Atlanta, Georgia, 30312

  • Forest Investigative Site 5

    Augusta, Georgia, 30904

  • Forest Investigative Site

    Baltimore, Maryland, 21204

  • Forest Investigative Site 20

    Baltimore, Maryland, 21209

  • Forest Investigative Site 35

    Bell Gardens, California, 90201

  • Forest Investigative Site

    Buena Park, California, 90620

  • Forest Investigative Site 51

    Centerville, Ohio, 45459

  • Forest Investigative Site 17

    Charleston, South Carolina, 29407

  • Forest Investigative Site 7

    Charlotte, North Carolina, 28211

  • Forest Investigative Site 45

    Charlotte, North Carolina, 28262

  • Forest Investigative Site 39

    Chicago, Illinois, 60607

  • Forest Investigative Site 54

    Chino, California, 91710

  • Forest Investigative Site 48

    Cincinnati, Ohio, 45242

  • Forest Investigative Site 46

    Columbia, South Carolina, 29201

  • Forest Investigative Site 52

    Corpus Christi, Texas, 78404

  • Forest Investigative Site 28

    Dallas, Texas, 75390

  • Forest Investigative Site 3

    Daytona Beach, Florida, 32117

  • Forest Investigative Site 33

    DeLand, Florida, 32720

  • Forest Investigative Site 40

    Fremont, California, 94538

  • Forest Investigative Site 61

    Golden, Colorado, 80401

  • Forest Investigative Site 36

    Hollywood, Florida, 33023

  • Forest Investigative Site 56

    Honolulu, Hawaii, 96814

  • Forest Investigative Site 16

    Huntsville, Alabama, 35801

  • Forest Investigative Site 38

    Hurst, Texas, 76054

  • Forest Investigative Site

    Kansas City, Missouri, 64111

  • Forest Investigative Site 57

    Meridian, Idaho, 83646

  • Forest Investigative Site 62

    Miami, Florida, 33135

  • Forest Investigative Site 080

    Miami, Florida, 33169

  • Forest Investigative Site 59

    Miami, Florida, 33183

  • Forest Investigative Site 24

    Morehead City, North Carolina, 28557

  • Forest Investigative Site

    New Hyde Park, New York, 11042

  • Forest Investigative Site 10

    New Tazewell, Tennessee, 37825

  • Forest Investigative Site

    New York, New York, 10032

  • Forest Investigative Site

    Norfolk, Virginia, 23502

  • Forest Investigative Site

    North Charleston, South Carolina, 29406

  • Forest Investigative Site 50

    Oxon Hill, Maryland, 20745

  • Forest Investigative Site

    Palm Springs, California, 92262

  • Forest Investigative Site 32

    Pembroke Pines, Florida, 33024

  • Forest Investigative Site 081

    Pembroke Pines, Florida, 33028

  • Forest Investigative Site

    Pomona, California, 91767

  • Forest Investigative Site 55

    Sacramento, California, 95821

  • Forest Investigative Site 21

    Saint Clair Shores, Michigan, 48081

  • Forest Investigative Site 26

    Salisbury, North Carolina, 28144

  • Forest Investigative Site 34

    Salt Lake City, Utah, 84102

  • Forest Investigative Site 11

    San Diego, California, 92128

  • Forest Investigative Site

    Santa Monica, California, 90404

  • Forest Investigative Site

    Simpsonville, South Carolina, 29681

  • Forest Investigative Site 4

    Sioux Falls, South Dakota, 57104

  • Forest Investigative Site

    Spring Valley, California, 91978

  • Forest Investigative Site

    St Louis, Missouri, 63110

  • Forest Investigative Site

    St. George, Utah, 84790

  • Forest Investigative Site 2

    Tamarac, Florida, 33321

  • Forest Investigative Site

    Tampa, Florida, 33612

  • Forest Investigative Site 49

    Tustin, California, 92780

  • Forest Investigative Site 31

    Virginia Beach, Virginia, 23452

  • Forest Investigative Site 12

    Wadsworth, Ohio, 44281

  • Forest Investigative Site 47

    Walnut Creek, California, 94598

  • Forest Investigative Site 19

    West Palm Beach, Florida, 33401

  • Forest Investigative Site

    Wheat Ridge, Colorado, 80033

  • Forest Investigative Site 37

    Wichita, Kansas, 67203

  • Forest Investigative Site 18

    Wilmington, North Carolina, 28401

Other trials in United States

Puerto Rico3 sites

  • Forest Investigative Site 41

    Ponce, 00717

  • Forest Investigative Site 60

    Salinas, 00751

  • Forest Investigative Site 29

    Santurce, 00909

Other trials in Puerto Rico

About this study

Official title: Glycemic Effects of Nebivolol Compared With Metoprolol Extended Release and Compared With Hydrochlorothiazide In Hypertensive Patients With Type 2 Diabetes Mellitus: A Pilot Study

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

Being tested
Nebivolol, Metoprolol ER, HCTZ
Keywords
nebivolol, Bystolic ™, Hypertension, Diabetes
Medical subject headings
Hypertension, Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

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

  • NebivololDrug

    Also called Bystolic (TM)

    • 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

  • Metoprolol ERDrug

    • 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

  • HCTZDrug

    Also called Hydrochlorothorazide

    • HCTZ 12.5 mg (overencapsulated 12.5 capsule), oral administration
    • HCTZ 25 mg (two capsules, overencapsulated 12.5-mg capsules), oral administration
Study groups in NCT00744237
Study groupRoleWhat they receive
1Experimental* 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
Receives: Drug: Nebivolol
2Active comparator* 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
Receives: Drug: Metoprolol ER
3Active comparator* 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
Receives: Drug: HCTZ

What is being measured

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

  1. 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.

    Measured: visit 5(week 0) and visit 14(week 26)

Secondary outcomes (1)

  1. 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

    Measured: [visit 5(week 0) and visit 14(week 26)]

Timeline

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

  1. First posted29 Aug 2008 (estimated)
  2. Study startAug 2008
  3. Primary completionJul 2010

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
231 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00744237
Sponsor's protocol ID
NEB-MD-19
Status last verified
Jun 2011
First submitted
27 Aug 2008
Last updated
29 Jul 2011
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Nebivolol, Metoprolol ER and HCTZ in people with Hypertension and Type 2 Diabetes Mellitus, run by Forest Laboratories at 65 sites in 2 countries.

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 6 inclusion and 12 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 29 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 65 sites in United States, Puerto Rico. 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 29 Jul 2011). 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?

Change From Baseline in Mean Glycosylated Hemoglobin (HbA1c) at Week 26 (time frame: visit 5(week 0) and visit 14(week 26)). 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 NCT00744237.

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 29 Jul 2011.

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