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

Primary Purpose

Hypertension

Status
Withdrawn
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Candesartan Cilexetil
Candesartan matching placebo
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Sponsored by
Bayer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring Drug combination, Nifedipine GITS, Candesartan Cilexetil, Hypertension, Combination therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers
  • 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

Sites / Locations

  • Fondazione Università G.D'Annunzio
  • A.O.U. di Bologna Policlinico S.Orsola Malpighi
  • AAS 3 Friuli Alto Medio Collin
  • Fondazione Salvatore Maugeri
  • IRCCS Ist Neurologico Mediterraneo
  • A.O.U. di Sassari
  • A.O.U. Pisana
  • AULSS 07 Pieve Soligo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Candesartan

Nifedipine/Candesartan-30/16

Nifedipine/Candesartan-60/16

Arm Description

Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan 16 mg, Placebo combination A, Placebo combination B)

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)

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)

Outcomes

Primary Outcome Measures

Change in mean seated systolic blood pressure (MSSBP).

Secondary Outcome Measures

Change in mean seated diastolic blood pressure (MSDBP).
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.
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.
Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours.
Number of participants with adverse events as a measure of safety and tolerability.

Full Information

First Posted
January 24, 2014
Last Updated
May 19, 2017
Sponsor
Bayer
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1. Study Identification

Unique Protocol Identification Number
NCT02047019
Brief Title
Monotherapy-Controlled Study of Nifedipine Gastrointestinal Therapeutic System and Candesartan Cilexetil in Combination in Subjects With Essential Hypertension Inadequately Controlled on Candesartan Cilexetil
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Withdrawn
Why Stopped
GPDC decided to terminate the study
Study Start Date
December 1, 2017 (Anticipated)
Primary Completion Date
December 8, 2019 (Anticipated)
Study Completion Date
December 8, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bayer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Drug combination, Nifedipine GITS, Candesartan Cilexetil, Hypertension, Combination therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Candesartan
Arm Type
Active Comparator
Arm Description
Treatment with 1 capsule and 2 tablets once daily in the morning for 8 weeks (Candesartan 16 mg, Placebo combination A, Placebo combination B)
Arm Title
Nifedipine/Candesartan-30/16
Arm Type
Experimental
Arm Description
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)
Arm Title
Nifedipine/Candesartan-60/16
Arm Type
Experimental
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 30/16 mg, tablet, orally, once daily
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16 mg, tablet, orally, once daily
Intervention Type
Drug
Intervention Name(s)
Candesartan Cilexetil
Intervention Description
Candesartan Cilexetil, 16 mg, capsule, orally, once daily
Intervention Type
Drug
Intervention Name(s)
Candesartan matching placebo
Intervention Description
Candesartan matching placebo, capsule, orally, once daily
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo, tablet, orally, once daily
Intervention Type
Drug
Intervention Name(s)
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)
Intervention Description
Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106), 60/16mg matching placebo, tablet, orally, once daily
Primary Outcome Measure Information:
Title
Change in mean seated systolic blood pressure (MSSBP).
Time Frame
From baseline to treatment week 8
Secondary Outcome Measure Information:
Title
Change in mean seated diastolic blood pressure (MSDBP).
Time Frame
From baseline to treatment week 8
Title
Blood pressure Response Rate
Description
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.
Time Frame
Treatment week 8
Title
Blood pressure Control Rate
Description
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.
Time Frame
Treatment week 8
Title
Mean change in systolic blood pressure and diastolic blood pressure in ambulatory blood pressure monitoring over 24 hours.
Time Frame
Treatment week 8
Title
Number of participants with adverse events as a measure of safety and tolerability.
Time Frame
Treatment week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bayer Study Director
Organizational Affiliation
Bayer
Official's Role
Study Director
Facility Information:
Facility Name
Fondazione Università G.D'Annunzio
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
A.O.U. di Bologna Policlinico S.Orsola Malpighi
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
AAS 3 Friuli Alto Medio Collin
City
Udine
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
33038
Country
Italy
Facility Name
Fondazione Salvatore Maugeri
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS Ist Neurologico Mediterraneo
City
Isernia
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
A.O.U. di Sassari
City
Sassari
State/Province
Sardegna
ZIP/Postal Code
07100
Country
Italy
Facility Name
A.O.U. Pisana
City
Pisa
State/Province
Toscana
ZIP/Postal Code
56126
Country
Italy
Facility Name
AULSS 07 Pieve Soligo
City
Treviso
State/Province
Veneto
ZIP/Postal Code
31029
Country
Italy

12. IPD Sharing Statement

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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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