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HypertensionPhase 3NCT02047019

Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil

A Phase 3 study testing Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) and Candesartan Cilexetil in people with Hypertension, run by Bayer at 8 sites in Italy.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone. 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) and Candesartan Cilexetil
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
0 participants
Where
8 sitesItaly
Study dates
1 Dec 2017to 8 Dec 2019
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Male and female subjects 18 years or older are eligible.
  • At Visit 0, subjects not treated with antihypertensive medications are to have MSSBP (mean seated systolic blood pressure) of >/= 160 mmHg and < 200 mmHg, and 24 hours MASBP (mean ambulatory systolic blood pressure) >/= 130 mmHg; those subjects treated with antihypertensive medication are to have MSSBP >/= 150 mmHg and < 200 mmHg as measured by a calibrated electronic BP measuring device
  • At Visit 3,subject must have MSSBP >/= 140 mmHg before randomization.
  • Women of childbearing potential and men must agree to use adequate contraception other than hormonal contraceptives when sexually active. This applies since signing of the IC (informed consent)form until the last study drug administration.

Who cannot join

  • Mean seated systolic blood pressure (MSSBP) >/= 200 mmHg and/or mean seated diastolic blood pressure (MSDBP) >/= 120 mm/Hg
  • Mean seated diastolic blood pressure (MSDBP) < 60 mm/Hg
  • Differences greater than 20 mmHg for systolic blood pressure (SBP) and 10 mmHg for diastolic blood pressure (DBP) are present on 3 consecutive blood pressure readings at visit 0
  • 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 hypertensive retinopathy - known Keith-Wagener Grade III or IV. Any history of heart failure, New York Heart Association (NYHA) classification III or IV
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  • Severe coronary heart disease as manifest by a history of myocardial infarction or unstable angina in the last 6 months prior to visit 0
  • Clinically significant cardiac valvular disease
  • Subjects with an aortic aneurysm that, in the opinion of the investigator, will be unsuitable to be enrolled in the study.
  • Type 1 diabetes mellitus (DM) or poorly controlled Type 2 DM as evidenced by glycosylated hemoglobin HbA1C of greater than 9% on visit 0

Trial locations and contacts

8 sites in 1 country.

8 sites in 1 country

Italy8 sites

  • A.O.U. di Bologna Policlinico S.Orsola Malpighi

    Bologna, Emilia-Romagna, 40138

  • Fondazione Università G.D'Annunzio

    Chieti, Abruzzo, 66100

  • IRCCS Ist Neurologico Mediterraneo

    Isernia, Molise, 86077

  • Fondazione Salvatore Maugeri

    Pavia, Lombardy, 27100

  • A.O.U. Pisana

    Pisa, Tuscany, 56126

  • A.O.U. di Sassari

    Sassari, Sardinia, 07100

  • AULSS 07 Pieve Soligo

    Treviso, Veneto, 31029

  • AAS 3 Friuli Alto Medio Collin

    Udine, Friuli Venezia Giulia, 33038

Other trials in Italy

About this study

Official title: A Multicenter, Randomized, Double-Blind, Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination Taken Orally for 8 Weeks in Adult Subjects With Essential Hypertension Who Are Inadequately Controlled on 16 mg Candesartan Cilexetil Monotherapy

This study examines the efficacy and safety of the Fixed Dose combination BAY98-7106 (nifedipine plus candesartan) in patients with hypertension, who do not achieve adequate control of blood pressure with candesartane alone.

Patients meeting the entry criteria, will receive candesartan alone 16mg in the first five weeks of the study to assess blood pressure control with candesartan given alone.

Patients with an insufficient therapeutic response to candesartan alone (defined by mean seated systolic blood pressure >/=140 mm/Hg) will enter the next part of the study, and will be randomly assigned to one of 3 treatments ( candesartan alone 16mg, combination nifedipine / candesartan 30/16 mg, combination nifedipine / candesartan 60/16 mg). Neither patient nor the treating physician will know which treatment is given (double-blinded design).This part of the study will last eight weeks.

Conditions
Hypertension
Being tested
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), Candesartan Cilexetil, Candesartan matching placebo, Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo
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), 30/16 mg, tablet, orally, once daily

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

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

  • Candesartan CilexetilDrug

    Candesartan Cilexetil, 16 mg, capsule, orally, once daily

  • Candesartan matching placeboDrug

    Candesartan matching placebo, capsule, orally, once daily

  • Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placeboDrug

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

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

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

Study groups in NCT02047019
Study groupRoleWhat they receive
CandesartanActive comparatorTreatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan 16 mg, Placebo combination A, Placebo combination B)
Receives: Drug: Candesartan Cilexetil; Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo; Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine/Candesartan-30/16ExperimentalTreatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan placebo, Placebo combination A, Combination nifedipine / candesartan 30/16 mg)
Receives: Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106); Drug: Candesartan matching placebo
Nifedipine/Candesartan-60/16ExperimentalTreatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan placebo, Placebo combination B, Combination nifedipine / candesartan 60/16 mg)
Receives: Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106); Drug: Candesartan matching placebo; Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo

What is being measured

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

  1. Change in mean seated systolic blood pressure (MSSBP).

    Measured: From baseline to treatment week 8

Secondary outcomes (5)

  1. Change in mean seated diastolic blood pressure (MSDBP).

    Measured: From baseline to treatment week 8

  2. Blood pressure Response Rate

    Response rate is defined as the percentage of subjects achieving a systolic blood pressure (SBP) response (MSSBP of < 140 mmHg or a reduction of MSSBP of > 20 mm Hg from baseline value), or a diastolic blood pressure (DBP) response (i.e. MSDBP of < 90 mmHg or a reduction of MSDBP of > 10 mm Hg from baseline value) after 8 weeks treatment.

    Measured: Treatment week 8

  3. Blood pressure Control Rate

    Control rate is the percentage of subjects that reach the predetermined blood pressure(BP) target < 140/90 mmHg. In addition, the percentage of subjects that reach the predetermined BP target < 140/90 mmHg for subjects without diabetes or chronic renal disorder(baseline estimated glomerular filtration rate(GFR) < 60 mL/min); <130/80 mmHg for subjects with diabetes or chronic renal disorder will be provided as well.

    Measured: Treatment week 8

  4. Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours.

    Measured: Treatment week 8

  5. Number of participants with adverse events as a measure of safety and tolerability.

    Measured: Treatment week 8

Timeline

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

  1. First posted28 Jan 2014 (estimated)
  2. Study start1 Dec 2017 (estimated)
  3. Primary completion8 Dec 2019 (estimated)
  4. Study completion8 Dec 2019 (estimated)

Why it stopped: GPDC decided to terminate the study

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02047019
Sponsor's protocol ID
14727
Other IDs
2012-004493-26
Status last verified
May 2017
First submitted
24 Jan 2014
Last updated
22 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) and Candesartan Cilexetil in people with Hypertension, run by Bayer at 8 sites in Italy.

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 4 inclusion and 10 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: withdrawn, as of the sponsor's last update on 22 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in Italy. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Change in mean seated systolic blood pressure (MSSBP). (time frame: From baseline to treatment week 8). 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 NCT02047019.

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 22 May 2017.

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