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

NCT01303783 | Completed Phase 2

• 2 other identifiers: 147252009-017077-37
• Study Type: interventional
• Target: 1,381
• Locations: 13 countries
• Sites: 157

Brief 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 regimens 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.

Conditions

Hypertension, Essential

Keywords

Nifedipine GITS; Candesartan; mild to moderate Hypertension; Combination therapy

Outcome Measures

Primary Outcomes (1)

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

  Baseline taken at Visit 1; primary outcome variable assesed at 8 weeks

Secondary Outcomes (5)

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

  8 weeks

• Control rate at Week 8

  8 weeks

• Response rate at Week 8

  8 weeks

• Peripheral Edema

  8 weeks

• Time to achieve first BP control

  8 weeks

Study Arms (16)

Nifedipine GITS 20 mg

EXPERIMENTAL

Subjects received 20 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule

Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo

Nifedipine GITS 30 mg

EXPERIMENTAL

Subjects received 30 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule

Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo

Nifedipine GITS 60 mg

EXPERIMENTAL

Subjects received 60 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule

Drug: Nifedipine GITS (Adalat, BAYA1040), 60 mg; Drug: Placebo

Candesartan cilexetil 4 mg

EXPERIMENTAL

Subjects received 4 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets

Drug: Candesartan cilexetil (Atacand), 4 mg; Drug: Placebo

Candesartan cilexetil 8 mg

EXPERIMENTAL

Subjects received 8 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets

Drug: Candesartan cilexetil (Atacand), 8 mg; Drug: Placebo

Candesartan cilexetil 16 mg

EXPERIMENTAL

Subjects received 16 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets

Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg

Candesartan cilexetil 32 mg

EXPERIMENTAL

Subjects received 32 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets

Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 32 mg

Nifedipine/candesartan 20/4 mg

EXPERIMENTAL

Subjects received the combination of 20 mg of nifedipine GITS/4 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Candesartan cilexetil (Atacand), 4 mg; Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo

Nifedipine/candesartan 20/8 mg

EXPERIMENTAL

Subjects received the combination of 20 mg of nifedipine GITS/8 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Candesartan cilexetil (Atacand), 8 mg; Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo

Nifedipine/candesartan 20/16 mg

EXPERIMENTAL

Subjects received the combination of 20 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg

Nifedipine/candesartan 30/8 mg

EXPERIMENTAL

Subjects received the combination of 30 mg of nifedipine GITS/8 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Candesartan cilexetil (Atacand), 8 mg; Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo

Nifedipine/candesartan 30/16 mg

EXPERIMENTAL

Subjects received the combination of 30 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg

Nifedipine/candesartan 30/32 mg

EXPERIMENTAL

Subjects received the combination of 30 mg of nifedipine GITS/32 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 32 mg

Nifedipine/candesartan 60/16 mg

EXPERIMENTAL

Subjects received the combination of 60 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Nifedipine GITS (Adalat, BAYA1040), 60 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg

Nifedipine/candesartan 60/32 mg

EXPERIMENTAL

Subjects received the combination of 60 mg of nifedipine GITS/32 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets

Drug: Nifedipine GITS (Adalat, BAYA1040), 60 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 32 mg

Placebo

PLACEBO COMPARATOR

Subjects received placebo (3 tablets and 1 capsule) once daily for 8 weeks

Drug: Placebo

Interventions

Candesartan cilexetil (Atacand), 4 mg DRUG

4 mg of candesartan as capsule

Candesartan cilexetil 4 mg; Nifedipine/candesartan 20/4 mg

Candesartan cilexetil (Atacand), 8 mg DRUG

8 mg candesartan as capsule

Candesartan cilexetil 8 mg; Nifedipine/candesartan 20/8 mg; Nifedipine/candesartan 30/8 mg

Nifedipine GITS (Adalat, BAYA1040), 20 mg DRUG

20 mg nifedipine as tablet

Nifedipine GITS 20 mg; Nifedipine/candesartan 20/16 mg; Nifedipine/candesartan 20/4 mg; Nifedipine/candesartan 20/8 mg

Nifedipine GITS (Adalat, BAYA1040), 30 mg DRUG

30 mg nifedipine as tablet

Nifedipine GITS 30 mg; Nifedipine/candesartan 30/16 mg; Nifedipine/candesartan 30/32 mg; Nifedipine/candesartan 30/8 mg

Nifedipine GITS (Adalat, BAYA1040), 60 mg DRUG

60 mg nifedipine as tablet

Nifedipine GITS 60 mg; Nifedipine/candesartan 60/16 mg; Nifedipine/candesartan 60/32 mg

Placebo DRUG

3 different placebo tablets corresponding nifedipine doses and 1 placebo capsule corresponding to candesartan doses

Candesartan cilexetil 16 mg; Candesartan cilexetil 32 mg; Candesartan cilexetil 4 mg; Candesartan cilexetil 8 mg; Nifedipine GITS 20 mg; Nifedipine GITS 30 mg; Nifedipine GITS 60 mg; Nifedipine/candesartan 20/16 mg; Nifedipine/candesartan 20/4 mg; Nifedipine/candesartan 20/8 mg; Nifedipine/candesartan 30/16 mg; Nifedipine/candesartan 30/32 mg; Nifedipine/candesartan 30/8 mg; Nifedipine/candesartan 60/16 mg; Nifedipine/candesartan 60/32 mg; Placebo

Candesartan cilexetil (Atacand), 16 mg DRUG

16 mg of candesartan as capsule

Candesartan cilexetil 16 mg; Nifedipine/candesartan 20/16 mg; Nifedipine/candesartan 30/16 mg; Nifedipine/candesartan 60/16 mg

Candesartan cilexetil (Atacand), 32 mg DRUG

32 mg of candesartan as capsule

Candesartan cilexetil 32 mg; Nifedipine/candesartan 30/32 mg; Nifedipine/candesartan 60/32 mg

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. 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (157)

Unknown Facility

Mobile, Alabama, 36617, United States

Location

Unknown Facility

Los Angeles, California, 90057, United States

Location

Unknown Facility

Coral Gables, Florida, 33114-4192, United States

Location

Unknown Facility

Deerfield Beach, Florida, 33321, United States

Location

Unknown Facility

Deerfield Beach, Florida, 33441, United States

Location

Unknown Facility

Fort Lauderdale, Florida, 33309, United States

Location

Unknown Facility

Jacksonville, Florida, 32216, United States

Location

Unknown Facility

West Palm Beach, Florida, 33409, United States

Location

Unknown Facility

Atlanta, Georgia, 30338, United States

Location

Unknown Facility

Valparaiso, Indiana, 46383, United States

Location

Unknown Facility

Charlotte, North Carolina, 28209, United States

Location

Unknown Facility

Harrisburg, North Carolina, 28075, United States

Location

Unknown Facility

Raleigh, North Carolina, 27609, United States

Location

Unknown Facility

Salisbury, North Carolina, 28144, United States

Location

Unknown Facility

Cincinnati, Ohio, 45224, United States

Location

Unknown Facility

Philadelphia, Pennsylvania, 19142, United States

Location

Unknown Facility

Greenville, South Carolina, 29615, United States

Location

Unknown Facility

Mt. Pleasant, South Carolina, 29464, United States

Location

Unknown Facility

Dallas, Texas, 75230, United States

Location

Unknown Facility

San Antonio, Texas, 78205, United States

Location

Unknown Facility

Salt Lake City, Utah, 84109, United States

Location

Unknown Facility

Salt Lake City, Utah, 84121, United States

Location

Unknown Facility

Kenosha, Wisconsin, 53142, United States

Location

Unknown Facility

Bahía Blanca, Buenos Aires, 8000, Argentina

Location

Unknown Facility

Quilmes, Buenos Aires, Argentina

Location

Unknown Facility

Zárate, Buenos Aires, B2800DGH, Argentina

Location

Unknown Facility

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

Location

Unknown Facility

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

Location

Unknown Facility

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

Location

Unknown Facility

Buenos Aires, Ciudad Auton. de Buenos Aires, C1425DES, Argentina

Location

Unknown Facility

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

Location

Unknown Facility

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

Location

Unknown Facility

Corrientes, Corrientes Province, 3400, Argentina

Location

Unknown Facility

Córdoba, Córdoba Province, 5000, Argentina

Location

Unknown Facility

Córdoba, Córdoba Province, X5002AOQ, Argentina

Location

Unknown Facility

Rosario, Santa Fe Province, 2000, Argentina

Location

Unknown Facility

Santa Fe, Santa Fe Province, 3000, Argentina

Location

Unknown Facility

Wetteren, Oost-Vlaanderen, 9230, Belgium

Location

Unknown Facility

De Pinte, 9840, Belgium

Location

Unknown Facility

Deurne, 2100, Belgium

Location

Unknown Facility

Ham, 3545, Belgium

Location

Unknown Facility

Fortaleza, Ceará, 60120-021, Brazil

Location

Unknown Facility

Brasília, Federal District, 71265 009, Brazil

Location

Unknown Facility

Goiânia, Goiás, 74605-050, Brazil

Location

Unknown Facility

Rio de Janeiro, Rio de Janeiro, 22271-100, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13010-001, Brazil

Location

Unknown Facility

Campinas, São Paulo, 13060904, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 01244-030, Brazil

Location

Unknown Facility

São Paulo, São Paulo, 04025-011, Brazil

Location

Unknown Facility

Langley, British Columbia, V3A 4H9, Canada

Location

Unknown Facility

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

Location

Unknown Facility

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

Location

Unknown Facility

Brampton, Ontario, L6T 0G1, Canada

Location

Unknown Facility

Corunna, Ontario, N0N 1G0, Canada

Location

Unknown Facility

Downsview, Ontario, M3J 1N2, Canada

Location

Unknown Facility

Etobicoke, Ontario, M8V 3X8, Canada

Location

Unknown Facility

London, Ontario, N5W 6A2, Canada

Location

Unknown Facility

London, Ontario, N5Y 5K7, Canada

Location

Unknown Facility

Newmarket, Ontario, L3Y 5G8, Canada

Location

Unknown Facility

Sarnia, Ontario, N7T 4X3, Canada

Location

Unknown Facility

Strathroy, Ontario, N7G 1Y7, Canada

Location

Unknown Facility

Toronto, Ontario, M9V 4B4, Canada

Location

Unknown Facility

Toronto, Ontario, M9W 4L6, Canada

Location

Unknown Facility

Montreal, Quebec, H4N 2W2, Canada

Location

Unknown Facility

Chieti, Abruzzo, 66013, Italy

Location

Unknown Facility

Bologna, Emilia-Romagna, 40138, Italy

Location

Unknown Facility

Trieste, Friuli Venezia Giulia, 34149, Italy

Location

Unknown Facility

Milan, Lombardy, 20132, Italy

Location

Unknown Facility

Pavia, Lombardy, 27100, Italy

Location

Unknown Facility

Sassari, Sardinia, 07100, Italy

Location

Unknown Facility

Pisa, Tuscany, 56124, Italy

Location

Unknown Facility

Perugia, Umbria, 06129, Italy

Location

Unknown Facility

Mercato San Severino, 84085, Italy

Location

Unknown Facility

Alytus, LT-62381, Lithuania

Location

Unknown Facility

Kaunas, LT-49387, Lithuania

Location

Unknown Facility

Kaunas, LT-50009, Lithuania

Location

Unknown Facility

Vilnius, LT-08661, Lithuania

Location

Unknown Facility

Moscow, 115432, Russia

Location

Unknown Facility

Moscow, 117997, Russia

Location

Unknown Facility

Moscow, 119048, Russia

Location

Unknown Facility

Moscow, 119415, Russia

Location

Unknown Facility

Moscow, 125284, Russia

Location

Unknown Facility

Saint Petersburg, 195112, Russia

Location

Unknown Facility

Saint Petersburg, 195271, Russia

Location

Unknown Facility

Saint Petersburg, 196247, Russia

Location

Unknown Facility

Saint Petersburg, 197022, Russia

Location

Unknown Facility

Saint Petersburg, 197341, Russia

Location

Unknown Facility

Saint Petersburg, 198013, Russia

Location

Unknown Facility

Saint Petersburg, 198205, Russia

Location

Unknown Facility

Saint Petersburg, 199106, Russia

Location

Unknown Facility

Smolensk, 214019, Russia

Location

Unknown Facility

Port Elizabeth, Eastern Cape, 6014, South Africa

Location

Unknown Facility

Johannesburg, Gauteng, South Africa

Location

Unknown Facility

Petoria, Gauteng, South Africa

Location

Unknown Facility

Roodepoort, Gauteng, 1724, South Africa

Location

Unknown Facility

Durban, KwaZulu-Natal, 4037, South Africa

Location

Unknown Facility

Witbank, Mpumalanga, 1035, South Africa

Location

Unknown Facility

Somerset West, Western Cape, 7130, South Africa

Location

Unknown Facility

Stellenbosch, Western Cape, 7505, South Africa

Location

Unknown Facility

Daejeon, Daejeon Gwang''yeogsi, 301-723, South Korea

Location

Unknown Facility

Wŏnju, Gang''weondo, 220-701, South Korea

Location

Unknown Facility

Anyang-si, Gyeonggido, 431-070, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggido, 410-719, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggido, 410-773, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggido, 411-706, South Korea

Location

Unknown Facility

Goyang-si, Gyeonggido, 412-270, South Korea

Location

Unknown Facility

Uijeongbu-si, Gyeonggido, 480-130, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 135-720, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 150-713, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 152-703, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 156-755, South Korea

Location

Unknown Facility

Seoul, Seoul Teugbyeolsi, 158 710, South Korea

Location

Unknown Facility

Busan, 602-793, South Korea

Location

Unknown Facility

Chungchungbuk-do, 361-711, South Korea

Location

Unknown Facility

Seoul, 110-744, South Korea

Location

Unknown Facility

Seoul, 120-752, South Korea

Location

Unknown Facility

Seoul, 133-792, South Korea

Location

Unknown Facility

Seoul, 150-950, South Korea

Location

Unknown Facility

Seoul, 156-707, South Korea

Location

Unknown Facility

Santiago de Compostela, A Coruña, 15706, Spain

Location

Unknown Facility

Benidorm, Alicante, 03503, Spain

Location

Unknown Facility

Petrel, Alicante, 03610, Spain

Location

Unknown Facility

Barcelona, Barcelona, 08036, Spain

Location

Unknown Facility

Hostalets de Balenyà, Barcelona, 08550, Spain

Location

Unknown Facility

Peralada, Girona, 17491, Spain

Location

Unknown Facility

Granada, Granada, 18012, Spain

Location

Unknown Facility

Huelva, Huelva, 21003, Spain

Location

Unknown Facility

Oviedo, Principality of Asturias, 33013, Spain

Location

Unknown Facility

Valencia, Valencia, 46006, Spain

Location

Unknown Facility

Dnipropetrovsk, 49060, Ukraine

Location

Unknown Facility

Kharkiv, 61176, Ukraine

Location

Unknown Facility

Kiev, 01 151, Ukraine

Location

Unknown Facility

Kiev, 01151, Ukraine

Location

Unknown Facility

Kiev, 02 091, Ukraine

Location

Unknown Facility

Kiev, 02660, Ukraine

Location

Unknown Facility

Kiev, 03680, Ukraine

Location

Unknown Facility

Vinnitsa, 2108, Ukraine

Location

Unknown Facility

Zaporizhzhya, 69118, Ukraine

Location

Unknown Facility

Zhytomyr, 10002, Ukraine

Location

Unknown Facility

Bath, Avon, BA2 4BY, United Kingdom

Location

Unknown Facility

Fowey, Cornwall, PL23 1DT, United Kingdom

Location

Unknown Facility

Penzance, Cornwall, TR18 4JH, United Kingdom

Location

Unknown Facility

Penzance, Cornwall, TR19 7HX, United Kingdom

Location

Unknown Facility

St Austell, Cornwall, PL26 7RL, United Kingdom

Location

Unknown Facility

Chesterfield, Derbyshire, S40 4AA, United Kingdom

Location

Unknown Facility

Glasgow, Glasgow City, G20 0XA, United Kingdom

Location

Unknown Facility

Glasgow, Glasgow City, G20 7LR, United Kingdom

Location

Unknown Facility

Blackpool, Lancashire, FY3 7EN, United Kingdom

Location

Unknown Facility

Bath, Somerset, BA3 2UH, United Kingdom

Location

Unknown Facility

Addlestone, Surrey, KT15 2BH, United Kingdom

Location

Unknown Facility

Coventry, Warwickshire, CV6 4DD, United Kingdom

Location

Unknown Facility

Royal Leamington Spa, Warwickshire, CV32 4RA, United Kingdom

Location

Unknown Facility

Chippenham, Wiltshire, SN15 2SB, United Kingdom

Location

Unknown Facility

Trowbridge, Wiltshire, BA14 8QA, United Kingdom

Location

Unknown Facility

Westbury, Wiltshire, BA13 3JD, United Kingdom

Location

Unknown Facility

Bath, BA11 2FH, United Kingdom

Location

Unknown Facility

Bath, BA2 4JT, United Kingdom

Location

Related Publications (2)

• Kjeldsen SE, Cha G, Villa G, Mancia G; DISTINCT Investigators. Nifedipine GITS/Candesartan Combination Therapy Lowers Blood Pressure Across Different Baseline Systolic and Diastolic Blood Pressure Categories: DISTINCT Study Subanalyses. J Clin Pharmacol. 2016 Sep;56(9):1120-9. doi: 10.1002/jcph.712. Epub 2016 Mar 7.

  PMID: 26829251 RESULT

• Kjeldsen SE, Sica D, Haller H, Cha G, Gil-Extremera B, Harvey P, Heyvaert F, Lewin AJ, Villa G, Mancia G; DISTINCT Investigators. Nifedipine plus candesartan combination increases blood pressure control regardless of race and improves the side effect profile: DISTINCT randomized trial results. J Hypertens. 2014 Dec;32(12):2488-98; discussion 2498. doi: 10.1097/HJH.0000000000000331.

  PMID: 25144296 DERIVED

Related Links

• Click here to find information about studies related to Bayer Healthcare products conducted in Europe.

MeSH Terms

Conditions

Essential Hypertension

Interventions

candesartan cilexetil; Nifedipine

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• 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: February 24, 2011
• First Posted: February 25, 2011
• Study Start: April 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: April 18, 2017

Record last verified: 2017-04

Locations

KR (20); BR (8); IT (9); AR (14); LI (4); UA (10); CA (15); RU (14); BE (4); US (23); GB (18); ZA (8); ES (10)