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

September 22, 2017 updated by: Bayer

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

508

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Deurne, Belgium, 2100
      • HAM, Belgium, 3545
    • Oost-Vlaanderen
      • Moorsel, Oost-Vlaanderen, Belgium, 9310
      • Wetteren, Oost-Vlaanderen, Belgium, 9230
    • Vlaams Brabant
      • Steenokkerzeel, Vlaams Brabant, Belgium, 1820
  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada, V5G 1T4
      • Langley, British Columbia, Canada, V3A 4H9
      • Vancouver, British Columbia, Canada, V5Z 1K3
    • Ontario
      • Brampton, Ontario, Canada, L6T 0G1
      • Burlington, Ontario, Canada, L7M 4Y1
      • Etobicoke, Ontario, Canada, M8V 3X8
      • London, Ontario, Canada, N5W 6A2
      • Newmarket, Ontario, Canada, L3Y 5G8
      • Sarnia, Ontario, Canada, N7T 4X3
      • Stayner, Ontario, Canada, L0M 1S0
      • Toronto, Ontario, Canada, M9V 4B4
      • Toronto, Ontario, Canada, M4S 1Y2
      • Woodstock, Ontario, Canada, N4S 4G3
    • Quebec
      • Pointe-Claire, Quebec, Canada, H9R 3J1
      • Ste-Foy, Quebec, Canada, G1W 1S2
  • Germany
      • Berlin, Germany, 12627
      • Dresden, Germany
    • Hessen
      • Frankfurt, Hessen, Germany, 60313
    • Nordrhein-Westfalen
      • Bochum, Nordrhein-Westfalen, Germany, 44787
    • Sachsen
      • Görlitz, Sachsen, Germany, 02826
      • Leipzig, Sachsen, Germany, 04103
    • Sachsen-Anhalt
      • Magdeburg, Sachsen-Anhalt, Germany, 39104
  • Poland
      • Gdynia, Poland, 81-384
      • Katowice, Poland, 40-040
      • Warszawa, Poland, 01-192
      • Wroclaw, Poland, 50-088
  • United Kingdom
      • Cardiff, United Kingdom, CF14 5GJ
      • Chorley, United Kingdom, PR7 7NA
      • Glasgow, United Kingdom, G20 OSP
      • Liverpool, United Kingdom, L22 0LG
      • Manchester, United Kingdom, M15 6SX
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 0TG
    • Derbyshire
      • Chesterfield, Derbyshire, United Kingdom, S40 4AA
    • Lancashire
      • Blackpool, Lancashire, United Kingdom, FY3 7EN
    • Somerset
      • Bath, Somerset, United Kingdom, BA3 2UH
    • Suffolk
      • Bury St Edmonds, Suffolk, United Kingdom, IP30 9QU
    • Warwickshire
      • Coventry, Warwickshire, United Kingdom, CV6 4DD
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2SQ
  • United States
    • Alabama
      • Foley, Alabama, United States, 36535
    • California
      • Carmichael, California, United States, 95608
      • Los Angeles, California, United States, 90057
      • Spring Valley, California, United States, 91978
    • Connecticut
      • Milford, Connecticut, United States, 06460
    • Florida
      • Coral Gables, Florida, United States, 33114-4192
      • Hallandale Beach, Florida, United States, 33009
      • Hollywood, Florida, United States, 33083
      • Jacksonville, Florida, United States, 32216
      • Jupiter, Florida, United States, 33458
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30338
    • Indiana
      • Valparaiso, Indiana, United States, 46383
    • Kansas
      • Newton, Kansas, United States, 67114
      • Wichita, Kansas, United States, 67205
    • Kentucky
      • Lexington, Kentucky, United States, 40504
    • Louisiana
      • New Orleans, Louisiana, United States, 70119
    • Maine
      • Auburn, Maine, United States, 04240
    • Maryland
      • Elkridge, Maryland, United States, 21075
    • Massachusetts
      • Brockton, Massachusetts, United States, 02301
    • Missouri
      • Saint Louis, Missouri, United States, 63141
    • North Carolina
      • Shelby, North Carolina, United States, 28150
    • Ohio
      • Cincinnati, Ohio, United States, 45246
      • Cincinnati, Ohio, United States, 45224
      • Cincinnati, Ohio, United States, 45245
      • Columbus, Ohio, United States, 43213
    • South Carolina
      • Greenville, South Carolina, United States, 29615
      • Mount Pleasant, South Carolina, United States, 29464
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
    • Tennessee
      • Nashville, Tennessee, United States, 37203
      • New Tazewell, Tennessee, United States, 37825
    • Texas
      • Beaumont, Texas, United States, 77701
      • Bryan, Texas, United States, 77802
      • Carrollton, Texas, United States, 75010
      • Dallas, Texas, United States, 75230
      • San Antonio, Texas, United States, 78229
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)
Subjects received nifedipine gastrointestinal therapeutic system (GITS) / candesartan cilexetil fixed dose combination (FDC) (BAY98-7106) tablet orally, once daily in the morning of Visit 1 (Week 0) for 28 or 52 weeks. The starting dose (30/8 milligram [mg] or 30/16 mg) was determined based on local practice and clinical judgment by the investigator. Based on the experience of symptomatic and asymptomatic hypotension, peripheral edema or significant tolerability, the doses were up-titrated to the highest target dose (60/32 mg).
Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily
Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily
Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily
Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 28
Time Frame: From the time of first study drug administration up to Week 28
An adverse event (AE) is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.
From the time of first study drug administration up to Week 28
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 28
Time Frame: From the time of first study drug administration up to Week 28
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.
From the time of first study drug administration up to Week 28
Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (EOS)
Time Frame: From the time of first study drug administration up to Week 52/EOS
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication.
From the time of first study drug administration up to Week 52/EOS
Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (EOS)
Time Frame: From the time of study treatment up to Week 52/EOS
An AE is any untoward medical occurrence (that is, any unfavorable and unintended sign [including abnormal laboratory findings], symptom or disease) in a subject or clinical investigation subject after providing written informed consent for participation in the study. AEs were considered to be treatment-emergent if they had started or worsened after first application of study medication. TEAEs of special interest included the incidence of symptomatic hypotension and the incidence and severity of vasodilatory adverse events (such as oedema, headache, and flushing). Only subjects who had TEAEs of special interest as mild, moderate or severe were reported.
From the time of study treatment up to Week 52/EOS

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Subjects With Clinically Relevant Changes in Laboratory Parameters
Time Frame: Baseline (Week 0) up to Week 52/EOS
Laboratory evaluations of blood and urine samples were performed, including hematology (hematocrit, hemoglobin, red blood cells count, white blood cells count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets), blood chemistry (sodium, potassium, chloride, bicarbonate, uric acid, total protein, albumin, calcium, blood urea nitrogen, creatinine, aspartate transaminase, alanine transaminase, lactate dehydrogenase, gamma glutamyl transferase, alkaline phosphatase, creatine kinase, total bilirubin, direct bilirubin, total cholesterol, low density lipoprotein cholesterol, high density lipoprotein cholesterol, triglycerides, fasting glucose), urinalysis (pH, blood, specific gravity, glucose, protein, cells/sediment). A laboratory test abnormality considered clinically relevant, for example, causing withdrawal by subject, requiring treatment or causing apparent clinical manifestations, or judged relevant by the investigator, were reported as AEs.
Baseline (Week 0) up to Week 52/EOS
Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52
Time Frame: Baseline (Week 0), Weeks 28 and 52
Baseline (Week 0), Weeks 28 and 52
Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52
Time Frame: Baseline (Week 0), Weeks 28 and 52
Baseline (Week 0), Weeks 28 and 52
Blood Pressure Control Rate at Weeks 28 and 52
Time Frame: Weeks 28 and 52
Control rate was defined as the percentage of subjects that reached a predetermined blood pressure (BP) target of BP less than (<) 140/90 mmHg.
Weeks 28 and 52
Blood Pressure Response Rate at Weeks 28 and 52
Time Frame: Weeks 28 and 52
Response rate was defined as the percentage of subjects who achieved a systolic blood pressure response (MSSBP of <140 mmHg or a reduction of MSSBP of more than (>) 20 mmHg from baseline value), or a diastolic blood pressure response (MSDBP of <90 mmHg or a reduction of MSDBP of >10 mmHg from baseline value).
Weeks 28 and 52

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2013

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

February 7, 2013

First Submitted That Met QC Criteria

February 7, 2013

First Posted (Estimate)

February 11, 2013

Study Record Updates

Last Update Posted (Actual)

October 24, 2017

Last Update Submitted That Met QC Criteria

September 22, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14801
  • 2012-004515-32 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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