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Trial record 59 of 143 for:    NIFEDIPINE

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

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ClinicalTrials.gov Identifier: NCT02047019
Recruitment Status : Withdrawn (GPDC decided to terminate the study)
First Posted : January 28, 2014
Last Update Posted : May 22, 2017
Sponsor:
Information provided by (Responsible Party):
Bayer

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Hypertension Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) Drug: Candesartan Cilexetil Drug: Candesartan matching placebo Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : December 1, 2017
Estimated Primary Completion Date : December 8, 2019
Estimated Study Completion Date : December 8, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Candesartan
Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan 16 mg, Placebo combination A, Placebo combination B)
Drug: Candesartan Cilexetil
Candesartan Cilexetil, 16 mg, capsule, orally, once daily

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

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

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

Drug: Candesartan matching placebo
Candesartan matching placebo, capsule, orally, once daily

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

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

Drug: Candesartan matching placebo
Candesartan matching placebo, capsule, orally, once daily

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




Primary Outcome Measures :
  1. Change in mean seated systolic blood pressure (MSSBP). [ Time Frame: From baseline to treatment week 8 ]

Secondary Outcome Measures :
  1. Change in mean seated diastolic blood pressure (MSDBP). [ Time Frame: From baseline to treatment week 8 ]
  2. Blood pressure Response Rate [ Time Frame: Treatment week 8 ]
    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.

  3. Blood pressure Control Rate [ Time Frame: Treatment week 8 ]
    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.

  4. Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours. [ Time Frame: Treatment week 8 ]
  5. Number of participants with adverse events as a measure of safety and tolerability. [ Time Frame: Treatment week 8 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria
  • Inclusion Criteria:
  • 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.
  • Exclusion Criteria:
  • 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
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02047019


Locations
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Italy
Fondazione Università G.D'Annunzio
Chieti, Abruzzo, Italy, 66100
A.O.U. di Bologna Policlinico S.Orsola Malpighi
Bologna, Emilia-Romagna, Italy, 40138
AAS 3 Friuli Alto Medio Collin
Udine, Friuli-Venezia Giulia, Italy, 33038
Fondazione Salvatore Maugeri
Pavia, Lombardia, Italy, 27100
IRCCS Ist Neurologico Mediterraneo
Isernia, Molise, Italy, 86077
A.O.U. di Sassari
Sassari, Sardegna, Italy, 07100
A.O.U. Pisana
Pisa, Toscana, Italy, 56126
AULSS 07 Pieve Soligo
Treviso, Veneto, Italy, 31029
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02047019     History of Changes
Other Study ID Numbers: 14727
2012-004493-26 ( EudraCT Number )
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: May 22, 2017
Last Verified: May 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Drug combination
Nifedipine GITS
Candesartan Cilexetil
Hypertension
Combination therapy
Additional relevant MeSH terms:
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Nifedipine
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
Candesartan
Candesartan cilexetil
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Vasodilator Agents
Tocolytic Agents
Reproductive Control Agents