NCT01218100 - Efficacy and Safety Study to Evaluate Combination Therapy With Nebivolol and Lisinopril vs. Placebo and Monotherapy in Patients With Stage 2 Diastolic Hypertension | Biotech Hunter

Enrollment

664

Participants

Timeline

Start Date

October 31, 2010

Primary Completion Date

May 31, 2011

Study Completion Date

June 30, 2011

Conditions

Stage 2 Diastolic Hypertension

Interventions

DRUG

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

nebivolol monotherapy

"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"

DRUG

lisinopril monotherapy

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

DRUG

placebo

Placebo tablet, oral administration/QD/oral administration/up to 12 weeks Placebo capsule, oral administration/QD/oral administration/up to 12 weeks

Trial Locations (90)

16684

Forest Investigative site 015, Tipton

19008

Forest Investigative site 011, Broomall

19146

Forest Investigative site 061, Philadelphia

21204

Forest Investigative site 021, Baltimore

21209

Forest Investigative site 069, Balitmore

21236

Forest Investigative site 014, Baltimore

23507

Forest Investigative site 031, Norfolk

23510

Forest Investigative site 041, Norfolk

27103

Forest Investigative site 022, Winston-Salem

27203

Forest Investigative site 065, Asheboro

27609

Forest Investigative site 101, Raleigh

27612

Forest Investigative site 024, Raleigh

28150

Forest Investigative site 013, Shelby

28204

Forest Investigative site 034, Charlotte

28209

Forest Investigative site 086, Charlotte

28601

Forest Investigative site 089, Hickory

28602

Forest Investigative site 094, Hickory

28645

Forest Investigative site 027, Lenoir

29407

Forest Investigative site 066, Charleston

29651

Forest Investigative site 048, Greer

30281

Forest Investigative site 055, Stockbridge

30338

Forest Investigative site 076, Atlanta

33012

Forest Investigative site 002, Hialeah

33014

Forest Investigative site 003, Miami

33024

Forest Investigative site 036, Pembroke Pines

33028

Forest Investigative site 005, Pembroke Pines

33133

Forest Investigative site 067, Miami

33143

Forest Investigative site 057, Miami

33169

Forest Investigative site 068, Miami

33183

Forest Investigative site 007, Miami

33306

Forest Investigative site 035, Fort Lauderdale

33432

Forest Investigative site 019, Boca Raton

33511

Forest Investigative site 056, Brandon

33606

Forest Investigative site 004, Tampa

33614

Forest Investigative site 046, Tampa

33709

Forest Investigative site 001, St. Petersburg

34601

Forest Investigative site 043, Brooksville

34652

Forest Investigative site 009, New Port Richey

37334

Forest Investigative site 052, Fayetteville

40213

Forest Investigative site 087, Louisville

42303

Forest Investigative site 060, Owensboro

42431

Forest Investigative site 099, Madisonville

43213

Forest Investigative site 084, Columbus

43701

Forest Investigative site 051, Zanesville

45227

Forest Investigative site 098, Cincinnati

45406

Forest Investigative site 026, Dayton

49464

Forest Investigative site 093, Mt. Pleasant

60490

Forest Investigative site 016, Chicago

60607

Forest Investigative site 085, Chicago

60611

Forest Investigative site 082, Chicago

61550

Forest Investigative site 039, Morton

63128

Forest Investigative site 095, St Louis

70115

Forest Investigative site 030, New Orleans

73069

Forest Investigative site 053, Norman

75006

Forest Investigative site 025, Carrollton

77074

Forest Investigative site 006, Houston

Forest Investigative site 029, Houston

78205

Forest Investigative site 047, San Antonio

78229

Forest Investigative site 071, San Antonio

80909

Forest Investigative site 077, Colorado Springs

83646

Forest Investigative site 008, Meridian

84102

Forest Investigative site 018, Salt Lake City

84124

Forest Investigative site 100, Salt Lake City

84790

Forest Investigative site 023, St. George

85254

Forest Investigative Site #58, Scottsdale

85282

Forest Investigative site 080, Tempe

85741

Forest Investigative site 096, Tucson

89104

Forest Investigative site 010, Las Vegas

89106

Forest Investigative site 012, Las Vegas

90057

Forest Investigative site 049, Los Angeles

90620

Forest Investigative site 038, Buena Park

90806

Forest Investigative site 097, Long Beach

91108

Forest Investigative site 040, San Marino

91505

Forest Investigative site 075, Burbank

92506

Forest Investigative site 081, Riverside

92626

Forest Investigative site 042, Costa Mesa

92705

Forest Investigative site 074, Santa Ana

92708

Forest Investigative site 028, Fountain Valley

92780

Forest Investigative site 072, Tustin

93539

Forest Investigative site 079, Lancaster

93726

Forest Investigative site 064, Fresno

94583

Forest Investigative site 059, San Ramon

96814

Forest Investigative Site 070, Honolulu

97520

Forest Investigative site 062, Ashland

98405

Forest Investigative site 078, Tacoma

06708

Forest Investigative site 050, Waterbury

02301

Forest Investigative site 054, Brockton

07202

Forest Investigative site 020, Elizabeth

02920

Forest Investigative site 045, Cranston

00725

Forest Investigative site 044, Caguas