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

NCT02047019 | Withdrawn Phase 3 FDA Drug

• 2 other identifiers: 147272012-004493-26
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 8

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.

Conditions

Hypertension

Keywords

Drug combination; Nifedipine GITS; Candesartan Cilexetil; Hypertension; Combination therapy

Outcome Measures

Primary Outcomes (1)

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

  From baseline to treatment week 8

Secondary Outcomes (5)

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

  From baseline to treatment week 8

• Blood pressure Response Rate

  Treatment week 8

• Blood pressure Control Rate

  Treatment week 8

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

  Treatment week 8

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

  Treatment week 8

Study Arms (3)

Candesartan

ACTIVE COMPARATOR

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; Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo; Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106)

Nifedipine/Candesartan-30/16

EXPERIMENTAL

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); Drug: Candesartan matching placebo

Nifedipine/Candesartan-60/16

EXPERIMENTAL

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); Drug: Candesartan matching placebo; Drug: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo

Interventions

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) DRUG

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

Nifedipine/Candesartan-30/16

Candesartan Cilexetil DRUG

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

Candesartan

Candesartan matching placebo DRUG

Candesartan matching placebo, capsule, orally, once daily

Nifedipine/Candesartan-30/16; Nifedipine/Candesartan-60/16

Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) 30/16mg matching placebo DRUG

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

Candesartan; Nifedipine/Candesartan-60/16

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (8)

Fondazione Università G.D'Annunzio

Chieti, Abruzzo, 66100, Italy

Location

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

Bologna, Emilia-Romagna, 40138, Italy

Location

AAS 3 Friuli Alto Medio Collin

Udine, Friuli Venezia Giulia, 33038, Italy

Location

Fondazione Salvatore Maugeri

Pavia, Lombardy, 27100, Italy

Location

IRCCS Ist Neurologico Mediterraneo

Isernia, Molise, 86077, Italy

Location

A.O.U. di Sassari

Sassari, Sardinia, 07100, Italy

Location

A.O.U. Pisana

Pisa, Tuscany, 56126, Italy

Location

AULSS 07 Pieve Soligo

Treviso, Veneto, 31029, Italy

Location

MeSH Terms

Conditions

Hypertension

Interventions

candesartan cilexetil

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 24, 2014
• First Posted: January 28, 2014
• Study Start: December 1, 2017
• Primary Completion: December 8, 2019
• Study Completion: December 8, 2019
• Last Updated: May 22, 2017

Record last verified: 2017-05

Locations

IT (8)