Stage 2 Diastolic HypertensionPhase 4NCT01218100

Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension

A Phase 4 study testing nebivolol and lisinopril (free combination), nebivolol monotherapy and lisinopril monotherapy in people with Stage 2 Diastolic Hypertension, run by Forest Laboratories at 90 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 safety and efficacy of first-line treatment with a free combination (as two separate pills) of nebivolol and lisinopril in patients with stage 2 diastolic hypertension (DBP>= 100 mmHg). Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Stage 2 Diastolic Hypertension
What is being tested?: nebivolol and lisinopril (free combination), nebivolol monotherapy and lisinopril monotherapy
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 664 participants
Where: 90 sitesin 2 countries
Study dates: Oct 2010to Jun 2011
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 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

male and female outpatients 18 to 64 years of age
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
stage 2 diastolic hypertension (DBP >= 100 mmHg)

Who cannot join

secondary hypertension
evidence of other concurrent disease or conditions that might interfere with the conduct of the study
participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, of Screening (Visit 1).
have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

Trial locations and contacts

90 sites in 2 countries.

Country

City, postcode or hospital

90 sites in 2 countries

United States89 sites

Forest Investigative site 065
Asheboro, North Carolina, 27203
Forest Investigative site 062
Ashland, Oregon, 97520
Forest Investigative site 076
Atlanta, Georgia, 30338
Forest Investigative site 069
Balitmore, Maryland, 21209
Forest Investigative site 021
Baltimore, Maryland, 21204
Forest Investigative site 014
Baltimore, Maryland, 21236
Forest Investigative site 019
Boca Raton, Florida, 33432
Forest Investigative site 056
Brandon, Florida, 33511
Forest Investigative site 054
Brockton, Massachusetts, 02301
Forest Investigative site 043
Brooksville, Florida, 34601
Forest Investigative site 011
Broomall, Pennsylvania, 19008
Forest Investigative site 038
Buena Park, California, 90620
Forest Investigative site 075
Burbank, California, 91505
Forest Investigative site 025
Carrollton, Texas, 75006
Forest Investigative site 066
Charleston, South Carolina, 29407
Forest Investigative site 034
Charlotte, North Carolina, 28204
Forest Investigative site 086
Charlotte, North Carolina, 28209
Forest Investigative site 016
Chicago, Illinois, 60490
Forest Investigative site 085
Chicago, Illinois, 60607
Forest Investigative site 082
Chicago, Illinois, 60611
Forest Investigative site 098
Cincinnati, Ohio, 45227
Forest Investigative site 077
Colorado Springs, Colorado, 80909
Forest Investigative site 084
Columbus, Ohio, 43213
Forest Investigative site 042
Costa Mesa, California, 92626
Forest Investigative site 045
Cranston, Rhode Island, 02920
Forest Investigative site 026
Dayton, Ohio, 45406
Forest Investigative site 020
Elizabeth, New Jersey, 07202
Forest Investigative site 052
Fayetteville, Tennessee, 37334
Forest Investigative site 035
Fort Lauderdale, Florida, 33306
Forest Investigative site 028
Fountain Valley, California, 92708
Forest Investigative site 064
Fresno, California, 93726
Forest Investigative site 048
Greer, South Carolina, 29651
Forest Investigative site 002
Hialeah, Florida, 33012
Forest Investigative site 089
Hickory, North Carolina, 28601
Forest Investigative site 094
Hickory, North Carolina, 28602
Forest Investigative Site 070
Honolulu, Hawaii, 96814
Forest Investigative site 006
Houston, Texas, 77074
Forest Investigative site 029
Houston, Texas, 77074
Forest Investigative site 079
Lancaster, California, 93539
Forest Investigative site 010
Las Vegas, Nevada, 89104
Forest Investigative site 012
Las Vegas, Nevada, 89106
Forest Investigative site 027
Lenoir, North Carolina, 28645
Forest Investigative site 097
Long Beach, California, 90806
Forest Investigative site 049
Los Angeles, California, 90057
Forest Investigative site 087
Louisville, Kentucky, 40213
Forest Investigative site 099
Madisonville, Kentucky, 42431
Forest Investigative site 008
Meridian, Idaho, 83646
Forest Investigative site 003
Miami, Florida, 33014
Forest Investigative site 067
Miami, Florida, 33133
Forest Investigative site 057
Miami, Florida, 33143
Forest Investigative site 068
Miami, Florida, 33169
Forest Investigative site 007
Miami, Florida, 33183
Forest Investigative site 039
Morton, Illinois, 61550
Forest Investigative site 093
Mt. Pleasant, South Carolina, 49464
Forest Investigative site 030
New Orleans, Louisiana, 70115
Forest Investigative site 009
New Port Richey, Florida, 34652
Forest Investigative site 031
Norfolk, Virginia, 23507
Forest Investigative site 041
Norfolk, Virginia, 23510
Forest Investigative site 053
Norman, Oklahoma, 73069
Forest Investigative site 060
Owensboro, Kentucky, 42303
Forest Investigative site 036
Pembroke Pines, Florida, 33024
Forest Investigative site 005
Pembroke Pines, Florida, 33028
Forest Investigative site 061
Philadelphia, Pennsylvania, 19146
Forest Investigative site 101
Raleigh, North Carolina, 27609
Forest Investigative site 024
Raleigh, North Carolina, 27612
Forest Investigative site 081
Riverside, California, 92506
Forest Investigative site 018
Salt Lake City, Utah, 84102
Forest Investigative site 100
Salt Lake City, Utah, 84124
Forest Investigative site 047
San Antonio, Texas, 78205
Forest Investigative site 071
San Antonio, Texas, 78229
Forest Investigative site 040
San Marino, California, 91108
Forest Investigative site 059
San Ramon, California, 94583
Forest Investigative site 074
Santa Ana, California, 92705
Forest Investigative Site #58
Scottsdale, Arizona, 85254
Forest Investigative site 013
Shelby, North Carolina, 28150
Forest Investigative site 095
St Louis, Missouri, 63128
Forest Investigative site 023
St. George, Utah, 84790
Forest Investigative site 001
St. Petersburg, Florida, 33709
Forest Investigative site 055
Stockbridge, Georgia, 30281
Forest Investigative site 078
Tacoma, Washington, 98405
Forest Investigative site 004
Tampa, Florida, 33606
Forest Investigative site 046
Tampa, Florida, 33614
Forest Investigative site 080
Tempe, Arizona, 85282
Forest Investigative site 015
Tipton, Pennsylvania, 16684
Forest Investigative site 096
Tucson, Arizona, 85741
Forest Investigative site 072
Tustin, California, 92780
Forest Investigative site 050
Waterbury, Connecticut, 06708
Forest Investigative site 022
Winston-Salem, North Carolina, 27103
Forest Investigative site 051
Zanesville, Ohio, 43701

Other trials in United States

Puerto Rico1 site

Forest Investigative site 044
Caguas, 00725

Other trials in Puerto Rico

About this study

Official title: A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension

Conditions: Stage 2 Diastolic Hypertension
Being tested: nebivolol and lisinopril (free combination), nebivolol monotherapy, lisinopril monotherapy, placebo

What participants receive

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

nebivolol and lisinopril (free combination)Drug
nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks
nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks
nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks
nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks
nebivolol monotherapyDrug
nebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks
nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only)
nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks
lisinopril monotherapyDrug
lisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks
placeboDrug
Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Study groups in NCT01218100
Study group	Role	What they receive
1	Experimental	Combination group - starting dose level nebivolol 5mg and lisinopril 10mg Receives: Drug: nebivolol and lisinopril (free combination)
2	Active comparator	Nebivolol monotherapy group - starting dose level nebivolol 5mg Receives: Drug: nebivolol monotherapy
3	Active comparator	Lisinopril monotherapy group - starting dose level lisinopril 10mg Receives: Drug: lisinopril monotherapy
4	Placebo comparator	Placebo group - starting dose is placebo Receives: Drug: placebo

What is being measured

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

The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.
Measured: Visit 6/(Week 0) and Visit 9/(Week 6)

Secondary outcomes (1)

The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.
Measured: Visit 6/(Week 0) and Visit 9/(Week 6)

Timeline

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

Oct 2010Jun 2011

First posted11 Oct 2010 (estimated)
Study startOct 2010
Primary completionMay 2011
Study completionJun 2011

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Stage 2 Diastolic 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 664 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01218100
Sponsor's protocol ID: NEB-MD-25
Status last verified: May 2012
First submitted: 7 Oct 2010
Last updated: 21 Jun 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Study at a glance

From the registry record, last updated by the sponsor on 21 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Parallel-Group Study to Evaluate the Effects of First-Line Treatment With a Free Combination of Nebivolol and Lisinopril Compared With Placebo and the Monotherapy Components on Blood Pressure in Patients With Stage 2 Diastolic Hypertension
ClinicalTrials.gov ID: NCT01218100
Acronym / sponsor ID: NEB-MD-25
Conditions: Stage 2 Diastolic Hypertension
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 664 participants (actual)
Lead sponsor: Forest LaboratoriesIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: May 2011 (actual)
Study completion: Jun 2011 (actual)
First posted: 11 Oct 2010 (estimated)
Results: Posted 21 Jun 2012

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
1	Experimental	Drug: nebivolol and lisinopril (free combination)Combination group - starting dose level nebivolol 5mg and lisinopril 10mg
2	Active comparator	Drug: nebivolol monotherapyNebivolol monotherapy group - starting dose level nebivolol 5mg
3	Active comparator	Drug: lisinopril monotherapyLisinopril monotherapy group - starting dose level lisinopril 10mg
4	Placebo comparator	Drug: placeboPlacebo group - starting dose is placebo

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (3 listed)

male and female outpatients 18 to 64 years of age
Females must be post-menopausal, or not pregnant and using an approved contraceptive regimen
stage 2 diastolic hypertension (DBP >= 100 mmHg)

Key exclusion criteria (4 listed)

secondary hypertension
evidence of other concurrent disease or conditions that might interfere with the conduct of the study
participation in an investigational drug study within 30 days or 5 half-lives, whichever is longer, of Screening (Visit 1).
have a history of hypersensitivity to nebivolol or other β-blockers, or any contraindication to β-blocker use

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 and lisinopril (free combination)nebivolol 5-mg and lisinopril 10-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 10-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 20-mg and lisinopril 40-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 10 weeks nebivolol 5-mg and lisinopril 40-mg (nebivolol non-trade 5-mg tablet and overencapsulated lisinopril 40-mg tablet)/QD/oral administration/up to 6 weeks nebivolol 20-mg and lisinopril 10-mg (nebivolol non-trade 20-mg tablet and overencapsulated lisinopril 10-mg tablet/QD/oral administration/up to 6 weeks	Drug	1
nebivolol monotherapynebivolol 5-mg (non-trade 5-mg tablet)/QD/oral administration/up to 12 weeks nebivolol 10-mg (non-trade 10-mg tablet/QD/oral administration/for 1-week down-titration period only) nebivolol 20-mg (non-trade 20-mg tablet)/QD/oral administration/up to 10 weeks	Drug	2
lisinopril monotherapylisinopril 10-mg (overencapsulated 10-mg tablet)/QD/oral administration/up to 12 weeks lisinopril 40-mg (overencapsulated 40-mg tablet)/QD/oral administration/up to 10 weeks	Drug	3
placeboPlacebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks	Drug	4

Primary outcome

The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.
Time frame: Visit 6/(Week 0) and Visit 9/(Week 6)

1 secondary outcome

The Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6.
Time frame: Visit 6/(Week 0) and Visit 9/(Week 6)

Results and safety

Results posted to the registry on 21 Jun 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	95	71
Nebivolol + Lisinopril (Combination)	190	165
Nebivolol	189	162
Lisinopril	190	156

Primary outcome: The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6.

Time frame: Visit 6/(Week 0) and Visit 9/(Week 6). Mean (Standard Deviation). Unit: mm HG

Measure	Placebo n = 93	Nebivolol + Lisinopril (Combination) n = 189	Nebivolol n = 185	Lisinopril n = 189
Value	-8.0 (9.2)	-17.2 (10.2)	-13.3 (8.9)	-12.0 (9.8)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event reporting occurred from October 6th, 2010 to May 18th, 2011.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	2 of 95 (2.1%)	15 of 95 (15.8%)	Not reported
Nebivolol + Lisinopril (Combination)	2 of 189 (1.1%)	31 of 189 (16.4%)	Not reported
Nebivolol	3 of 188 (1.6%)	32 of 188 (17%)	Not reported
Lisinopril	4 of 189 (2.1%)	24 of 189 (12.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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.

Manfred Stapff, MD PhD study director

Forest Laboratories

90 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 3 inclusion and 4 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 21 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 90 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. Some participants in this study may receive a placebo. 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 21 Jun 2012). 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?

The Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6. (time frame: Visit 6/(Week 0) and Visit 9/(Week 6)). 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 NCT01218100.

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 21 Jun 2012.