Clinical trial NCT01788358: Open-Label Long-Term Safety and Efficacy Study of Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Subjects With Moderate to Severe Essential Hypertension
Official title: Multicenter, Open-Label, Long-Term Safety and Efficacy Study of the Fixed Dose Combination of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Adult Subjects With Moderate to Severe Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Keywords: Drug combination
Nifedipine GITS
Candesartan Cilexetil
Hypertension
Combination therapy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2013-02-11
Enrollment: 508
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study examines the long term safety and efficacy of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan primarily at the highest dose in development) in patients with moderate to severe hypertension.

Patients meeting the entry criteria, will receive the Fixed Dose combination for 28 weeks, including 8 weeks with stepwise dose increase up to the high target dose. The first 200 subjects completing 28 weeks will continue treatment for additional 24 weeks (52 weeks in total).

Subjects who do not tolerate an increased dose will be treated at their highest tolerable dose.


Eligibility criteria: Inclusion Criteria:

* Subjects must have moderate to severe essential hypertension (Grade 2 or Grade 3, WHO classifications). At Visit 1, subjects not treated with antihypertensive medications are to have MSSBP of \>/= 160 mmHg and \< 200 mmHg, as measured by a calibrated electronic BP measuring device. For other subjects who are treated with antihypertensive medication before, they should have MSSBP \>/= 160 mmHg and \<200 mmHg after wash out.
* Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active

Exclusion Criteria:

* Mean seated systolic blood pressure \>/= 200 mmHg and/or mean seated diastolic blood pressure \>/= 120 mm/Hg
* Mean seated diastolic blood pressure \< 60 mm/Hg
* Differences greater than 20 mmHg for systolic blood pressure and 10 mmHg for diastolic blood pressure are present on 3 consecutive blood pressure readings at visit 0
* Any history of hypertensive emergency
* Evidence of secondary hypertension such as coarctation of the aorta, pheochromocytoma, hyperaldosteronism, etc.
* Cerebrovascular ischemic event (stroke, transient ischemic attack \[TIA\])within the previous 12 months
* History of intracerebral hemorrhage or subarachnoid hemorrhage
* History of hypertensive retinopathy - known Keith-Wagener Grade III or IV
* Any history of heart failure, New York Heart Association (NYHA) classification III or IV
* Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
* Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by HbA1C of greater than 9% on visit 0.
* Hyperkalemia: potassium above the upper limit of normal in the laboratory range

Primary outcomes:
measure: Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28
timeFrame: From the time of first study drug administration up to Week 28
measure: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
timeFrame: From the time of first study drug administration up to Week 28
measure: Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)
timeFrame: From the time of first study drug administration up to Week 52/EOS
measure: Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
timeFrame: From the time of study treatment up to Week 52/EOS
Secondary outcomes:
measure: Number of Subjects With Clinically Relevant Changes in Laboratory Parameters
timeFrame: Baseline (Week 0) up to Week 52/EOS
measure: Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
timeFrame: Baseline (Week 0), Weeks 28 and 52
measure: Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52
timeFrame: Baseline (Week 0), Weeks 28 and 52
measure: Blood Pressure Control Rate at Weeks 28 and 52
timeFrame: Weeks 28 and 52
measure: Blood Pressure Response Rate at Weeks 28 and 52
timeFrame: Weeks 28 and 52
Other outcomes:
Locations:
city: Foley
country: United States
state: Alabama
city: Carmichael
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Spring Valley
country: United States
state: California
city: Milford
country: United States
state: Connecticut
city: Coral Gables
country: United States
state: Florida
city: Hallandale Beach
country: United States
state: Florida
city: Hollywood
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jupiter
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Valparaiso
country: United States
state: Indiana
city: Newton
country: United States
state: Kansas
city: Wichita
country: United States
state: Kansas
city: Lexington
country: United States
state: Kentucky
city: New Orleans
country: United States
state: Louisiana
city: Auburn
country: United States
state: Maine
city: Elkridge
country: United States
state: Maryland
city: Brockton
country: United States
state: Massachusetts
city: Saint Louis
country: United States
state: Missouri
city: Shelby
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Greenville
country: United States
state: South Carolina
city: Mount Pleasant
country: United States
state: South Carolina
city: Rapid City
country: United States
state: South Dakota
city: Nashville
country: United States
state: Tennessee
city: New Tazewell
country: United States
state: Tennessee
city: Beaumont
country: United States
state: Texas
city: Bryan
country: United States
state: Texas
city: Carrollton
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Kenosha
country: United States
state: Wisconsin
city: Moorsel
country: Belgium
state: Oost-Vlaanderen
city: Wetteren
country: Belgium
state: Oost-Vlaanderen
city: Steenokkerzeel
country: Belgium
state: Vlaams Brabant
city: Deurne
country: Belgium
city: HAM
country: Belgium
city: Burnaby
country: Canada
state: British Columbia
city: Langley
country: Canada
state: British Columbia
city: Vancouver
country: Canada
state: British Columbia
city: Brampton
country: Canada
state: Ontario
city: Burlington
country: Canada
state: Ontario
city: Etobicoke
country: Canada
state: Ontario
city: London
country: Canada
state: Ontario
city: Newmarket
country: Canada
state: Ontario
city: Sarnia
country: Canada
state: Ontario
city: Stayner
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Woodstock
country: Canada
state: Ontario
city: Pointe-Claire
country: Canada
state: Quebec
city: Ste-Foy
country: Canada
state: Quebec
city: Frankfurt
country: Germany
state: Hessen
city: Bochum
country: Germany
state: Nordrhein-Westfalen
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Görlitz
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Berlin
country: Germany
city: Dresden
country: Germany
city: Gdynia
country: Poland
city: Katowice
country: Poland
city: Warszawa
country: Poland
city: Wroclaw
country: Poland
city: Reading
country: United Kingdom
state: Berkshire
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Blackpool
country: United Kingdom
state: Lancashire
city: Bath
country: United Kingdom
state: Somerset
city: Bury St Edmonds
country: United Kingdom
state: Suffolk
city: Coventry
country: United Kingdom
state: Warwickshire
city: Birmingham
country: United Kingdom
state: West Midlands
city: Cardiff
country: United Kingdom
city: Chorley
country: United Kingdom
city: Glasgow
country: United Kingdom
city: Liverpool
country: United Kingdom
city: Manchester
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: