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Study of Nifedipine GITS and Candesartan Combination Compared to Monotherapy in Patients With Essential Hypertension

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

Condition(s) targeted: Hypertension

Intervention: Candersartan (Drug); Candersartan (Drug); Candersartan (Drug); Nifedipine (Adalat, BAYA1040) (Drug); Nifedipine (Adalat, BAYA1040) (Drug); Nifedipine (Adalat, BAYA1040) (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Nifedipine GITS/Candersartan (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Bayer

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

Summary

The purpose of this study is to determine the blood pressure lowering responses of various dose combinations of nifedipine GITS and candesartan as compared to treatment with each component on their own (monotherapy) and placebo (a look-alike tablet without active

ingredient). The drugs - nifedipine GITS and candesartan - which are being investigated are

currently approved for use in patients with essential hypertension alone or together with other antihypertensive drugs (combination therapy), but the optimal dose of nifedipine GITS and candesartan used together in the treatment of essential hypertension has not been established yet. In this study patients will be treated with various doses of nifedipine GITS and/or candesartan or placebo. These different regimes will be administered once a day and will be assessed based on their blood pressure lowering effects (mean sitting diastolic blood pressure) in subjects with mild to moderate essential hypertension.

Clinical Details

Official title: A Multicenter, Multifactorial, Randomized, Double-Blind, Placebo-Controlled Dose Finding Study of Nifedipine GITS and Candesartan in Combination Compared to Monotherapy in Adult Patients With Essential Hypertension

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

Primary outcome: The primary efficacy variable is the change from baseline in mean seated diastolic blood pressure (MSDBP) at Week 8

Secondary outcome:

Change in mean seated systolic blood pressure (MSSBP) at Week 8

Control rate at Week 8

Response rate at Week 8

Peripheral Edema

Eligibility

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

Criteria:

Inclusion Criteria:

- Male and female subjects 18 years or older. Female subjects must be either

post-menopausal for one year, surgically sterile, or using an effective contraceptive method. Hormonal contraceptive use is disallowed.

- Subjects must have mild to moderate essential hypertension (Grade 1 and 2 WHO

classifications) as measured by calibrated standard sphygmomanometer. (MSDBP of ≥90 mmHg and < 110 mmHg at Visit 1 (placebo run-in), and MSDBP of ≥95 mmHg and < 110 mmHg at visit 2 (randomization)

- Subjects must have an absolute difference in their MSDBP of less than 10 mmHg between

Visit 1 (placebo run- in) and Visit 2 (randomization). Exclusion Criteria:

- Severe hypertension (Grade 3 WHO classification; MSDBP ≥110 mmHg and/or MSSBP ≥ 180

mmHg)

- Inability to washout of antihypertensive drugs (even if prescribed for another

indication) safely for a period of 14 weeks.

- History of hypertensive retinopathy - known Keith-Wagener Grade III or IV

- History of hypertensive encephalopathy

- Cerebrovascular ischemic event (stroke, transient ischemic attack [TIA])within the

previous 12 months

- History of intracerebral hemorrhage or subarachnoid hemorrhage

- Evidence of secondary hypertension such as coarchation of the aorta,

pheochromocytoms, hypersaldosteronism, etc.

- Type I diabetes mellitus (DM) or poorly controlled DM Type II as evidenced by a

glycosylated hemoglobin [HbA1C] of greater than 9% on visit 1.

- Allergies or known intolerance to one of the investigational drugs/drug class or to

one of their ingredients

- 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 1.

- Clinically significant cardiac valvular disease

- History of malignancy in the last 5 years, excluding basal or skin cancer

- Uncorrected hypokalemia or hyperkalemia: potassium outside 3. 0-5. 0 mmol/L

- Surgical or medical conditions that might alter the metabolism, excretion or

distribution or absorption of any drug 1. Gastrointestinal disease or surgery resulting in the potential for malabsorption 2. Severe gastrointestinal tract narrowing; kock pouch (ileostomy after proctocolectomy) 3. Cholestasis or biliary obstruction or history of pancreatic injury or clinical significant increase of lipase, amylase, or bilirubin. 4. Liver disease or AST/ALT levels >3 x ULN 5. Renal failure, creatinine level >1. 4 mg/dL, or on hemodialysis

- Investigation trial participation with receipt of investigational study drug within

the last month

- Previous assignment to treatment in this study

- Female subjects who are pregnant or lactating.

- Subjects who have night employment (night shift).

- Subjects with an aortic aneurysm that, in the opinion of the investigator, will be

unsuitable to be enrolled in the study.

- Thought by the investigator for any reason to be unsuitable for participation in a

clinical study

- Systemic use of known cytochrome P450-3A4 inhibitors (e. g cimetidine, anti-human

immunodeficiency virus [HIV] protease inhibitors e. g. ritonavir, azole anti-mycotics eg. ketoconazole,) or inducers (e. g rifampicin, anti-epileptic drugs eg. phenytoin, carbamazepine and phenobarbitone) or some P450-3A4 substrates (e. g quinidine, digoxin, tacrolimus)

- Present severe rhythm or conduction disorder:

- Atrial fibrillation

- Second or third degree heart block without a pacemaker.

- Baseline QTc >450 msec

- History of non-compliance, alcoholism or drug abuse that in the opinion of the

investigator will compromise successful completion of the study.

- If differences greater than 20 mmHg for SBP and 10 mmHg for DBP are present on 3

consecutive BP readings, the subject should be excluded from the study.

Locations and Contacts

Corrientes 3400, Argentina

Córdoba 5000, Argentina

Córdoba X5002AOQ, Argentina

Santa Fe 3000, Argentina

De Pinte 9840, Belgium

Deurne 2100, Belgium

HAM 3545, Belgium

Rio de Janeiro 22271-100, Brazil

Sao Paulo 01244-030, Brazil

Bologna 40138, Italy

Chieti 66013, Italy

Milano 20132, Italy

Pavia 27100, Italy

Perugia 06129, Italy

Pisa 56124, Italy

Sassari 07100, Italy

Trieste 34149, Italy

Goyang 410-719, Korea, Republic of

Pusan 602-793, Korea, Republic of

Seoul 110-799, Korea, Republic of

Seoul 133792, Korea, Republic of

Alytus LT-62381, Lithuania

Kaunas LT-49387, Lithuania

Kaunas LT-5009, Lithuania

Vilnius LT-08661, Lithuania

Moscow 119415, Russian Federation

Moscow 117997, Russian Federation

Moscow 119048, Russian Federation

Moscow 109432, Russian Federation

Moscow 125284, Russian Federation

Smolensk 214019, Russian Federation

St Petersburg 198013, Russian Federation

St. Petersburg 198205, Russian Federation

St. Petersburg 195112, Russian Federation

St. Petersburg 195271, Russian Federation

St. Petersburg 196247, Russian Federation

St. Petersburg 197022, Russian Federation

St. Petersburg 194341, Russian Federation

St. Petersburg 199106, Russian Federation

Barcelona 08036, Spain

Granada 18003, Spain

Huelva 21005, Spain

Valencia 46006, Spain

Dnipropetrovsk 49060, Ukraine

Kharkiv 61176, Ukraine

Kiev 01 151, Ukraine

Kiev 01151, Ukraine

Kiev 02 091, Ukraine

Kiev 02660, Ukraine

Kiev 03680, Ukraine

Vinnitsa 2108, Ukraine

Zaporizhzhya 69118, Ukraine

Zhytomyr 10002, Ukraine

Bath BA2 4JT, United Kingdom

Santiago de Compostela, A Coruña 15706, Spain

Mobile, Alabama 36617, United States

Benidorm, Alicante 03503, Spain

Petrer, Alicante 03610, Spain

Oviedo, Asturias 33013, Spain

Bath, Avon BA11 1EZ, United Kingdom

Bath, Avon BA2 4BY, United Kingdom

Hostalets de Balenyà, Barcelona 08550, Spain

Langley, British Columbia V3A 4H9, Canada

Bahía Blanca, Buenos Aires 8000, Argentina

Zárate, Buenos Aires B2800DGH, Argentina

Los Angeles, California 90057, United States

Fortaleza, Ceará 60120-021, Brazil

Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires C1280AEB, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires C1425AWC, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires 1405, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires C1440AAD, Argentina

Buenos Aires, Ciudad Auton. de Buenos Aires C1430AAQ, Argentina

Fowey, Cornwall PL23 1DT, United Kingdom

Penzance, Cornwall TR18 4JH, United Kingdom

Penzance, Cornwall TR19 7HX, United Kingdom

St Austell, Cornwall PL26 7RL, United Kingdom

Daejeon, Daejeon Gwang''yeogsi, Korea, Republic of

Chesterfield, Derbyshire S40 4TF, United Kingdom

Brasília, Distrito Federal 71265 009, Brazil

Port Elizabeth, Eastern Cape 6014, South Africa

Coral Gables, Florida 33114-4192, United States

Deerfield Beach, Florida 33441, United States

Deerfield Beach, Florida 33321, United States

Ft. Lauderdale, Florida 33309, United States

Jacksonville, Florida 32216, United States

West Palm Beach, Florida 33409, United States

Wonju, Gang''weondo, Korea, Republic of

Johannesburg, Gauteng, South Africa

Petoria, Gauteng, South Africa

Roodepoort, Gauteng 1724, South Africa

Atlanta, Georgia 30338, United States

Peralada, Girona 17491, Spain

Glasgow, Glasgow City G20 0XA, United Kingdom

Glasgow, Glasgow City G20 7LR, United Kingdom

Goiania, Goiás 74605-050, Brazil

Anyang, Gyeonggido 431-070, Korea, Republic of

Goyang-si, Gyeonggido 411-706, Korea, Republic of

Goyang, Gyeonggido 410-773, Korea, Republic of

Goyang, Gyeonggido 412-270, Korea, Republic of

Uijeongbu, Gyeonggido 480-130, Korea, Republic of

Valparaiso, Indiana 46383, United States

Chungchungbuk-do, Korea 361-711, Korea, Republic of

Durban, KwaZulu Natal 4037, South Africa

Blackpool, Lancashire FY3 7EN, United Kingdom

Witbank, Mpumalanga 1035, South Africa

St. John's, Newfoundland and Labrador A1A 3R5, Canada

St. John's, Newfoundland and Labrador A1E 2E2, Canada

Charlotte, North Carolina 28209, United States

Harrisburg, North Carolina 28075, United States

Raleigh, North Carolina 27609, United States

Salisbury, North Carolina 28144, United States

Cincinnati, Ohio 45224, United States

Brampton, Ontario L6T 0G1, Canada

Corunna, Ontario N0N 1G0, Canada

Downsview, Ontario M3J 1N2, Canada

Etobicoke, Ontario M8V 3X8, Canada

London, Ontario N5W 6A2, Canada

London, Ontario N5Y 5K7, Canada

Newmarket, Ontario L3Y 5G8, Canada

Sarnia, Ontario N7T 4X3, Canada

Strathroy, Ontario N7G 1Y7, Canada

Toronto, Ontario M9V 4B4, Canada

Toronto, Ontario M9W 4L6, Canada

Wetteren, Oost-Vlaanderen 9230, Belgium

Philadelphia, Pennsylvania 19142, United States

Montreal, Quebec H4N 2W2, Canada

Mercato San Severino, Salerno 84085, Italy

Rosario, Santa Fe 2000, Argentina

Campinas, Sao Paulo 13010-001, Brazil

Campinas, Sao Paulo 13059-900, Brazil

São Paulo, Sao Paulo 04025-011, Brazil

Seoul, Seoul Teugbyeolsi, Korea, Republic of

Seoul, Seoul Teugbyeolsi 150-713, Korea, Republic of

Seoul, Seoul Teugbyeolsi 152-703, Korea, Republic of

Seoul, Seoul Teugbyeolsi 156-707, Korea, Republic of

Seoul, Seoul Teugbyeolsi 158 710, Korea, Republic of

Seoul, Seoul Teugbyeolsi 135-720, Korea, Republic of

Bath, Somerset BA3 2UH, United Kingdom

Greenville, South Carolina 29615, United States

Mt. Pleasant, South Carolina 29464, United States

Addlestone, Surrey KT15 2BH, United Kingdom

Dallas, Texas 75230, United States

San Antonio, Texas 78205, United States

Salt Lake City, Utah 84109, United States

Salt Lake City, Utah 84121, United States

Coventry, Warwickshire CV6 4DD, United Kingdom

Leamington Spa, Warwickshire CV32 4RA, United Kingdom

Kenosha, Washington 53142, United States

Somerset West, Western Cape 7130, South Africa

Stellenbosch, Western Cape 7505, South Africa

Chippenham, Wiltshire SN15 2SB, United Kingdom

Trowbridge, Wiltshire BA14 8QA, United Kingdom

Westbury, Wiltshire BA13 3JD, United Kingdom

Additional Information

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Starting date: April 2011
Last updated: June 5, 2015

Page last updated: August 23, 2015

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