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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

Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Hypertension

Intervention: Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) (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 (Drug); Nifedipine GITS/Candesartan Cilexetil FDC(BAY98-7106) (Drug)

Phase: Phase 3

Status: Not yet recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

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

Clinical Details

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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change in mean seated systolic blood pressure (MSSBP)

Secondary outcome:

Change in mean seated diastolic blood pressure (MSDBP)

Blood pressure Response Rate

Blood pressure Control Rate

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

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Bayer Clinical Trials Contact, Email: clinical-trials-contact@bayerhealthcare.com

Córdoba 5008, Argentina; Not yet recruiting

Deurne 2100, Belgium; Not yet recruiting

HAM 3545, Belgium; Not yet recruiting

Canada, Canada; Not yet recruiting

Havirov-Mesto 736 01, Czech Republic; Not yet recruiting

Hodonin 695 01, Czech Republic; Not yet recruiting

Jicin 506 01, Czech Republic; Not yet recruiting

Plzen 301 00, Czech Republic; Not yet recruiting

Praha 11 148 00, Czech Republic; Not yet recruiting

Praha 13 158 00, Czech Republic; Not yet recruiting

Praha 1 110 00, Czech Republic; Not yet recruiting

Praha 4 140 21, Czech Republic; Not yet recruiting

Praha 6 169 00, Czech Republic; Not yet recruiting

Praha-Michle 141 00, Czech Republic; Not yet recruiting

Bourges 18000, France; Not yet recruiting

LA CHAPELLE sur ERDRE 44240, France; Not yet recruiting

Murs Erigne 49610, France; Not yet recruiting

Toulouse 31059, France; Not yet recruiting

Vihiers 49310, France; Not yet recruiting

Bologna 40138, Italy; Not yet recruiting

Chieti 66100, Italy; Not yet recruiting

Pavia 27100, Italy; Not yet recruiting

Pisa 56126, Italy; Not yet recruiting

Sassari 07100, Italy; Not yet recruiting

Alytus LT-62381, Lithuania; Not yet recruiting

Kaunas LT-49387, Lithuania; Not yet recruiting

Kaunas LT-49449, Lithuania; Not yet recruiting

Kaunas LT-50161, Lithuania; Not yet recruiting

Kaunas LT-51028, Lithuania; Not yet recruiting

Klaipeda LT-94231, Lithuania; Not yet recruiting

Lithuania LT-08661, Lithuania; Not yet recruiting

Moscow 119415, Russian Federation; Not yet recruiting

Moscow 109432, Russian Federation; Terminated

Russia, Russian Federation; Terminated

St Petersburg 198013, Russian Federation; Not yet recruiting

St. Petersburg 195112, Russian Federation; Not yet recruiting

St. Petersburg 197341, Russian Federation; Not yet recruiting

Granada 18003, Spain; Not yet recruiting

Huelva 21003, Spain; Not yet recruiting

Madrid 28046, Spain; Not yet recruiting

Zaragoza 50009, Spain; Not yet recruiting

Ankara 06010, Turkey; Not yet recruiting

Istanbul 34093, Turkey; Not yet recruiting

Istanbul 34730, Turkey; Not yet recruiting

Kocaeli 41380, Turkey; Not yet recruiting

Sivas 58140, Turkey; Not yet recruiting

Inverness IV2 4AG, United Kingdom; Not yet recruiting

Mobile, Alabama 36617, United States; Not yet recruiting

Petrer, Alicante 03610, Spain; Not yet recruiting

Bath, Avon BA2 3HT, United Kingdom; Not yet recruiting

Karlsruhe, Baden-Württemberg 76199, Germany; Not yet recruiting

Meßkirch, Baden-Württemberg 88605, Germany; Not yet recruiting

Hostalets de Balenyà, Barcelona 08550, Spain; Not yet recruiting

Großheirath-Rossach, Bayern 96269, Germany; Not yet recruiting

Nürnberg, Bayern 90402, Germany; Not yet recruiting

Wallerfing, Bayern 94574, Germany; Not yet recruiting

Baulers, Brabant Wallon 4163, Belgium; Not yet recruiting

Buena Park, California 90620-3888, United States; Not yet recruiting

Lincoln, California 95648, United States; Not yet recruiting

Roseville, California 95661-2847, United States; Not yet recruiting

Tustin, California 92780, United States; Not yet recruiting

Buenos Aires, Ciudad Auton. de Buenos Aires 1405, Argentina; Not yet recruiting

Buenos Aires, Ciudad Auton. de Buenos Aires C1425DES, Argentina; Not yet recruiting

Buenos Aires, Ciudad Auton. de Buenos Aires C1440AAD, Argentina; Not yet recruiting

Penzance, Cornwall TR18 4JH, United Kingdom; Not yet recruiting

Penzance, Cornwall TR19 7HX, United Kingdom; Not yet recruiting

St Austell, Cornwall PL26 7RL, United Kingdom; Not yet recruiting

Pozzilli, Isernia 86077, Italy; Not yet recruiting

Hasselt, Limburg 3500, Belgium; Not yet recruiting

Tavier, Liège 1401, Belgium; Not yet recruiting

St. Louis, Missouri 63128, United States; Not yet recruiting

Natoye, Namur 5360, Belgium; Not yet recruiting

Hannover, Niedersachsen 30625, Germany; Not yet recruiting

Essen, Nordrhein-Westfalen 45355, Germany; Not yet recruiting

Charlotte, North Carolina 28209, United States; Not yet recruiting

Salisbury, North Carolina 28144, United States; Not yet recruiting

Collingwood, Ontario L9Y 1W3, Canada; Not yet recruiting

Orleans, Ontario K4A 5E6, Canada; Not yet recruiting

Sarnia, Ontario N7T 4X3, Canada; Not yet recruiting

Moorsel, Oost-Vlaanderen 9310, Belgium; Not yet recruiting

Wetteren, Oost-Vlaanderen 9230, Belgium; Not yet recruiting

Montreal, Quebec H4N 2W2, Canada; Not yet recruiting

Rosario, Santa Fe 2000, Argentina; Not yet recruiting

Mt. Pleasant, South Carolina 29464, United States; Not yet recruiting

Addlestone, Surrey KT15 2BH, United Kingdom; Not yet recruiting

Knoxville, Tennessee 37920, United States; Not yet recruiting

Houston, Texas 77081, United States; Not yet recruiting

San Antonio, Texas 78205, United States; Not yet recruiting

Vittorio Veneto, Treviso 31029, Italy; Not yet recruiting

San Daniele del Friuli, Udine 33038, Italy; Not yet recruiting

Quart de Poblet, Valencia, Spain; Not yet recruiting

Steenokkerzeel, Vlaams Brabant 1820, Belgium; Not yet recruiting

Leamington Spa, Warwickshire CV32 4RA, United Kingdom; Not yet recruiting

Chippenham, Wiltshire SN15 2SB, United Kingdom; Not yet recruiting

Trowbridge, Wiltshire BA14 8QA, United Kingdom; Not yet recruiting

Trowbridge, Wiltshire BA14 9AR, United Kingdom; Not yet recruiting

Westbury, Wiltshire BA13 3JD, United Kingdom; Not yet recruiting

Additional Information

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Starting date: December 2016
Last updated: August 11, 2015

Page last updated: August 23, 2015

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