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HypertensionPhase 3NCT01788358

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

A Phase 3 study testing Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) in people with Hypertension, run by Bayer at 82 sites in 6 countries.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
508 participants
Where
82 sitesin 6 countries
Study dates
14 Feb 2013to 1 May 2014
Phase
Phase 3
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 12Show fewer
  • 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

Trial locations and contacts

82 sites in 6 countries.

82 sites in 6 countries

United States39 sites

  • Study site

    Atlanta, Georgia, 30338

  • Study site

    Auburn, Maine, 04240

  • Study site

    Beaumont, Texas, 77701

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Bryan, Texas, 77802

  • Study site

    Carmichael, California, 95608

  • Study site

    Carrollton, Texas, 75010

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Cincinnati, Ohio, 45245

  • Study site

    Cincinnati, Ohio, 45246

  • Study site

    Columbus, Ohio, 43213

  • Study site

    Coral Gables, Florida, 33114-4192

  • Study site

    Dallas, Texas, 75230

  • Study site

    Elkridge, Maryland, 21075

  • Study site

    Foley, Alabama, 36535

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Hallandale, Florida, 33009

  • Study site

    Hollywood, Florida, 33083

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jupiter, Florida, 33458

  • Study site

    Kenosha, Wisconsin, 53142

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Los Angeles, California, 90057

  • Study site

    Milford, Connecticut, 06460

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Orleans, Louisiana, 70119

  • Study site

    New Tazewell, Tennessee, 37825

  • Study site

    Newton, Kansas, 67114

  • Study site

    Rapid City, South Dakota, 57702

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78229

  • Study site

    Shelby, North Carolina, 28150

  • Study site

    Spring Valley, California, 91978

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Tampa, Florida, 33606

  • Study site

    Valparaiso, Indiana, 46383

  • Study site

    Wichita, Kansas, 67205

Other trials in United States

Canada15 sites

  • Study site

    Brampton, Ontario, L6T 0G1

  • Study site

    Burlington, Ontario, L7M 4Y1

  • Study site

    Burnaby, British Columbia, V5G 1T4

  • Study site

    Etobicoke, Ontario, M8V 3X8

  • Study site

    Langley, British Columbia, V3A 4H9

  • Study site

    London, Ontario, N5W 6A2

  • Study site

    Newmarket, Ontario, L3Y 5G8

  • Study site

    Pointe-Claire, Quebec, H9R 3J1

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

    Stayner, Ontario, L0M 1S0

  • Study site

    Ste-Foy, Quebec, G1W 1S2

  • Study site

    Toronto, Ontario, M4S 1Y2

  • Study site

    Toronto, Ontario, M9V 4B4

  • Study site

    Vancouver, British Columbia, V5Z 1K3

  • Study site

    Woodstock, Ontario, N4S 4G3

Other trials in Canada

United Kingdom12 sites

  • Study site

    Bath, Somerset, BA3 2UH

  • Study site

    Birmingham, West Midlands, B15 2SQ

  • Study site

    Blackpool, Lancashire, FY3 7EN

  • Study site

    Bury Saint Edmonds, Suffolk, IP30 9QU

  • Study site

    Cardiff, CF14 5GJ

  • Study site

    Chesterfield, Derbyshire, S40 4AA

  • Study site

    Chorley, PR7 7NA

  • Study site

    Coventry, Warwickshire, CV6 4DD

  • Study site

    Glasgow, G20 OSP

  • Study site

    Liverpool, L22 0LG

  • Study site

    Manchester, M15 6SX

  • Study site

    Reading, Berkshire, RG2 0TG

Other trials in United Kingdom

Germany7 sites

  • Study site

    Berlin, 12627

  • Study site

    Bochum, North Rhine-Westphalia, 44787

  • Study site

    Dresden

  • Study site

    Frankfurt am Main, Hesse, 60313

  • Study site

    Görlitz, Saxony, 02826

  • Study site

    Leipzig, Saxony, 04103

  • Study site

    Magdeburg, Saxony-Anhalt, 39104

Other trials in Germany

Belgium5 sites

  • Study site

    Deurne, 2100

  • Study site

    Ham, 3545

  • Study site

    Moorsel, Oost-Vlaanderen, 9310

  • Study site

    Steenokkerzeel, Vlaams Brabant, 1820

  • Study site

    Wetteren, Oost-Vlaanderen, 9230

Other trials in Belgium

Poland4 sites

  • Study site

    Gdynia, 81-384

  • Study site

    Katowice, 40-040

  • Study site

    Warsaw, 01-192

  • Study site

    Wroclaw, 50-088

Other trials in Poland

About this study

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

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.

Conditions
Hypertension
Being tested
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Keywords
Drug combination, Nifedipine GITS, Candesartan Cilexetil, Hypertension, Combination therapy
Medical subject headings
Hypertension

What participants receive

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

  • Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)Drug

    Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/8 mg, orally once daily

  • Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)Drug

    Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 30/16 mg, orally once daily

  • Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)Drug

    Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/16 mg, orally once daily

  • Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)Drug

    Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), tablet, 60/32 mg, orally once daily

Study groups in NCT01788358
Study groupRoleWhat they receive
Nifedipine GITS/Candesartan Cilexetil FDC (BAY98-7106)ExperimentalSubjects 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).
Receives: Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

What is being measured

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

  1. Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs 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.

    Measured: From the time of first study drug administration up to Week 28

  2. Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest 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.

    Measured: From the time of first study drug administration up to Week 28

  3. Number of Subjects With All Treatment-emergent Adverse Events (TEAEs) and Drug-related TEAEs up to Week 52/End of Study (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.

    Measured: From the time of first study drug administration up to Week 52/EOS

  4. Number of Subjects With Treatment-emergent Adverse Events (TEAEs) of Special Interest up to Week 52/End of Study (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.

    Measured: From the time of study treatment up to Week 52/EOS

Secondary outcomes (5)

  1. Number of Subjects With Clinically Relevant Changes in Laboratory Parameters

    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.

    Measured: Baseline (Week 0) up to Week 52/EOS

  2. Change From Baseline In Mean Seated Systolic Blood Pressure (MSSBP) At Weeks 28 And 52

    Measured: Baseline (Week 0), Weeks 28 and 52

  3. Change From Baseline in Mean Seated Diastolic Blood Pressure (MSDBP) at Weeks 28 and 52

    Measured: Baseline (Week 0), Weeks 28 and 52

  4. Blood Pressure Control Rate at 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.

    Measured: Weeks 28 and 52

  5. Blood Pressure Response Rate at 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).

    Measured: Weeks 28 and 52

Timeline

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

  1. First posted11 Feb 2013 (estimated)
  2. Study start14 Feb 2013
  3. Primary completion1 May 2014
  4. Study completion1 May 2014

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
508 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01788358
Sponsor's protocol ID
14801
Other IDs
2012-004515-32
Status last verified
Sep 2017
First submitted
7 Feb 2013
Last updated
24 Oct 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) in people with Hypertension, run by Bayer at 82 sites in 6 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 2 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 24 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Canada, United Kingdom, Germany, Belgium and 1 more country. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 17 Aug 2015). 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?

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). The study lists 4 primary outcomes in all. 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 NCT01788358.

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 24 Oct 2017.

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