AzTrials
AzTrials

Hypertension, EssentialPhase 2DISTINCTNCT01303783

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

A Phase 2 study testing Candesartan cilexetil (Atacand), 4 mg, Candesartan cilexetil (Atacand), 8 mg and Nifedipine GITS (Adalat, BAYA1040), 20 mg in people with Hypertension, Essential, run by Bayer at 157 sites in 13 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension, Essential
What is being tested?
Candesartan cilexetil (Atacand), 4 mg, Candesartan cilexetil (Atacand), 8 mg and Nifedipine GITS (Adalat, BAYA1040), 20 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,381 participants
Where
157 sitesin 13 countries
Study dates
Apr 2011to May 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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).

Who cannot join

  • 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
Show all 33Show fewer
  • 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
  • Gastrointestinal disease or surgery resulting in the potential for malabsorption
  • Severe gastrointestinal tract narrowing; kock pouch (ileostomy after proctocolectomy)
  • Cholestasis or biliary obstruction or history of pancreatic injury or clinical significant increase of lipase, amylase, or bilirubin.
  • Liver disease or AST/ALT levels >3 x ULN
  • Renal insufficiency, defined as eGFR of < 50 mL/min (computed using the Cockroft-Gault formula), 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.

Trial locations and contacts

157 sites in 13 countries.

157 sites in 13 countries

United States23 sites

  • Study site

    Atlanta, Georgia, 30338

  • Study site

    Charlotte, North Carolina, 28209

  • Study site

    Cincinnati, Ohio, 45224

  • Study site

    Coral Gables, Florida, 33114-4192

  • Study site

    Dallas, Texas, 75230

  • Study site

    Deerfield Beach, Florida, 33321

  • Study site

    Deerfield Beach, Florida, 33441

  • Study site

    Fort Lauderdale, Florida, 33309

  • Study site

    Greenville, South Carolina, 29615

  • Study site

    Harrisburg, North Carolina, 28075

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Kenosha, Wisconsin, 53142

  • Study site

    Los Angeles, California, 90057

  • Study site

    Mobile, Alabama, 36617

  • Study site

    Mt. Pleasant, South Carolina, 29464

  • Study site

    Philadelphia, Pennsylvania, 19142

  • Study site

    Raleigh, North Carolina, 27609

  • Study site

    Salisbury, North Carolina, 28144

  • Study site

    Salt Lake City, Utah, 84109

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    San Antonio, Texas, 78205

  • Study site

    Valparaiso, Indiana, 46383

  • Study site

    West Palm Beach, Florida, 33409

Other trials in United States

South Korea20 sites

  • Study site

    Anyang-si, Gyeonggido, 431-070

  • Study site

    Busan, 602-793

  • Study site

    Chungchungbuk-do, 361-711

  • Study site

    Daejeon, Daejeon Gwang''yeogsi, 301-723

  • Study site

    Goyang-si, Gyeonggido, 410-719

  • Study site

    Goyang-si, Gyeonggido, 410-773

  • Study site

    Goyang-si, Gyeonggido, 411-706

  • Study site

    Goyang-si, Gyeonggido, 412-270

  • Study site

    Seoul, Seoul Teugbyeolsi, 135-720

  • Study site

    Seoul, Seoul Teugbyeolsi, 150-713

  • Study site

    Seoul, Seoul Teugbyeolsi, 152-703

  • Study site

    Seoul, Seoul Teugbyeolsi, 156-755

  • Study site

    Seoul, Seoul Teugbyeolsi, 158 710

  • Study site

    Seoul, 110-744

  • Study site

    Seoul, 120-752

  • Study site

    Seoul, 133-792

  • Study site

    Seoul, 150-950

  • Study site

    Seoul, 156-707

  • Study site

    Uijeongbu-si, Gyeonggido, 480-130

  • Study site

    Wŏnju, Gang''weondo, 220-701

Other trials in South Korea

United Kingdom18 sites

  • Study site

    Addlestone, Surrey, KT15 2BH

  • Study site

    Bath, Avon, BA2 4BY

  • Study site

    Bath, Somerset, BA3 2UH

  • Study site

    Bath, BA11 2FH

  • Study site

    Bath, BA2 4JT

  • Study site

    Blackpool, Lancashire, FY3 7EN

  • Study site

    Chesterfield, Derbyshire, S40 4AA

  • Study site

    Chippenham, Wiltshire, SN15 2SB

  • Study site

    Coventry, Warwickshire, CV6 4DD

  • Study site

    Fowey, Cornwall, PL23 1DT

  • Study site

    Glasgow, Glasgow City, G20 0XA

  • Study site

    Glasgow, Glasgow City, G20 7LR

  • Study site

    Penzance, Cornwall, TR18 4JH

  • Study site

    Penzance, Cornwall, TR19 7HX

  • Study site

    Royal Leamington Spa, Warwickshire, CV32 4RA

  • Study site

    St Austell, Cornwall, PL26 7RL

  • Study site

    Trowbridge, Wiltshire, BA14 8QA

  • Study site

    Westbury, Wiltshire, BA13 3JD

Other trials in United Kingdom

Canada15 sites

  • Study site

    Brampton, Ontario, L6T 0G1

  • Study site

    Corunna, Ontario, N0N 1G0

  • Study site

    Downsview, Ontario, M3J 1N2

  • Study site

    Etobicoke, Ontario, M8V 3X8

  • Study site

    Langley, British Columbia, V3A 4H9

  • Study site

    London, Ontario, N5W 6A2

  • Study site

    London, Ontario, N5Y 5K7

  • Study site

    Montreal, Quebec, H4N 2W2

  • Study site

    Newmarket, Ontario, L3Y 5G8

  • Study site

    Sarnia, Ontario, N7T 4X3

  • Study site

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

  • Study site

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

  • Study site

    Strathroy, Ontario, N7G 1Y7

  • Study site

    Toronto, Ontario, M9V 4B4

  • Study site

    Toronto, Ontario, M9W 4L6

Other trials in Canada

Argentina14 sites

  • Study site

    Bahía Blanca, Buenos Aires, 8000

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, 1405

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1280AEB

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425AWC

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1425DES

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1430AAQ

  • Study site

    Buenos Aires, Ciudad Auton. de Buenos Aires, C1440AAD

  • Study site

    Córdoba, Córdoba Province, 5000

  • Study site

    Córdoba, Córdoba Province, X5002AOQ

  • Study site

    Corrientes, Corrientes Province, 3400

  • Study site

    Quilmes, Buenos Aires

  • Study site

    Rosario, Santa Fe Province, 2000

  • Study site

    Santa Fe, Santa Fe Province, 3000

  • Study site

    Zárate, Buenos Aires, B2800DGH

Other trials in Argentina

Russia14 sites

  • Study site

    Moscow, 115432

  • Study site

    Moscow, 117997

  • Study site

    Moscow, 119048

  • Study site

    Moscow, 119415

  • Study site

    Moscow, 125284

  • Study site

    Saint Petersburg, 195112

  • Study site

    Saint Petersburg, 195271

  • Study site

    Saint Petersburg, 196247

  • Study site

    Saint Petersburg, 197022

  • Study site

    Saint Petersburg, 197341

  • Study site

    Saint Petersburg, 198013

  • Study site

    Saint Petersburg, 198205

  • Study site

    Saint Petersburg, 199106

  • Study site

    Smolensk, 214019

Other trials in Russia

Spain10 sites

  • Study site

    Barcelona, Barcelona, 08036

  • Study site

    Benidorm, Alicante, 03503

  • Study site

    Granada, Granada, 18012

  • Study site

    Hostalets de Balenyà, Barcelona, 08550

  • Study site

    Huelva, Huelva, 21003

  • Study site

    Oviedo, Principality of Asturias, 33013

  • Study site

    Peralada, Girona, 17491

  • Study site

    Petrel, Alicante, 03610

  • Study site

    Santiago de Compostela, A Coruña, 15706

  • Study site

    Valencia, Valencia, 46006

Other trials in Spain

Ukraine10 sites

  • Study site

    Dnipropetrovsk, 49060

  • Study site

    Kharkiv, 61176

  • Study site

    Kiev, 01 151

  • Study site

    Kiev, 01151

  • Study site

    Kiev, 02 091

  • Study site

    Kiev, 02660

  • Study site

    Kiev, 03680

  • Study site

    Vinnitsa, 2108

  • Study site

    Zaporizhzhya, 69118

  • Study site

    Zhytomyr, 10002

Other trials in Ukraine

Italy9 sites

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Chieti, Abruzzo, 66013

  • Study site

    Mercato San Severino, 84085

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Perugia, Umbria, 06129

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Sassari, Sardinia, 07100

  • Study site

    Trieste, Friuli Venezia Giulia, 34149

Other trials in Italy

Brazil8 sites

  • Study site

    Brasília, Federal District, 71265 009

  • Study site

    Campinas, São Paulo, 13010-001

  • Study site

    Campinas, São Paulo, 13060904

  • Study site

    Fortaleza, Ceará, 60120-021

  • Study site

    Goiânia, Goiás, 74605-050

  • Study site

    Rio de Janeiro, Rio de Janeiro, 22271-100

  • Study site

    São Paulo, São Paulo, 01244-030

  • Study site

    São Paulo, São Paulo, 04025-011

Other trials in Brazil

South Africa8 sites

  • Study site

    Durban, KwaZulu-Natal, 4037

  • Study site

    Johannesburg, Gauteng

  • Study site

    Petoria, Gauteng

  • Study site

    Port Elizabeth, Eastern Cape, 6014

  • Study site

    Roodepoort, Gauteng, 1724

  • Study site

    Somerset West, Western Cape, 7130

  • Study site

    Stellenbosch, Western Cape, 7505

  • Study site

    Witbank, Mpumalanga, 1035

Other trials in South Africa

Belgium4 sites

  • Study site

    De Pinte, 9840

  • Study site

    Deurne, 2100

  • Study site

    Ham, 3545

  • Study site

    Wetteren, Oost-Vlaanderen, 9230

Other trials in Belgium

Lithuania4 sites

  • Study site

    Alytus, LT-62381

  • Study site

    Kaunas, LT-49387

  • Study site

    Kaunas, LT-50009

  • Study site

    Vilnius, LT-08661

Other trials in Lithuania

About this study

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

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.

Being tested
Candesartan cilexetil (Atacand), 4 mg, Candesartan cilexetil (Atacand), 8 mg, Nifedipine GITS (Adalat, BAYA1040), 20 mg, Nifedipine GITS (Adalat, BAYA1040), 30 mg, Nifedipine GITS (Adalat, BAYA1040), 60 mg
Keywords
Nifedipine GITS, Candesartan, mild to moderate Hypertension, Combination therapy
Medical subject headings
Essential Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Candesartan cilexetil (Atacand), 4 mgDrug

    4 mg of candesartan as capsule

  • Candesartan cilexetil (Atacand), 8 mgDrug

    8 mg candesartan as capsule

  • Nifedipine GITS (Adalat, BAYA1040), 20 mgDrug

    20 mg nifedipine as tablet

  • Nifedipine GITS (Adalat, BAYA1040), 30 mgDrug

    30 mg nifedipine as tablet

  • Nifedipine GITS (Adalat, BAYA1040), 60 mgDrug

    60 mg nifedipine as tablet

  • PlaceboDrug

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

  • Candesartan cilexetil (Atacand), 16 mgDrug

    16 mg of candesartan as capsule

  • Candesartan cilexetil (Atacand), 32 mgDrug

    32 mg of candesartan as capsule

Study groups in NCT01303783
Study groupRoleWhat they receive
Nifedipine GITS 20 mgExperimentalSubjects received 20 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo
Nifedipine GITS 30 mgExperimentalSubjects received 30 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo
Nifedipine GITS 60 mgExperimentalSubjects received 60 mg of nifedipine GITS (single tablet) monotherapy once daily for 8 weeks along with 2 placebo tablets and 1 placebo capsule
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 60 mg; Drug: Placebo
Candesartan cilexetil 4 mgExperimentalSubjects received 4 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets
Receives: Drug: Candesartan cilexetil (Atacand), 4 mg; Drug: Placebo
Candesartan cilexetil 8 mgExperimentalSubjects received 8 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets
Receives: Drug: Candesartan cilexetil (Atacand), 8 mg; Drug: Placebo
Candesartan cilexetil 16 mgExperimentalSubjects received 16 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets
Receives: Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg
Candesartan cilexetil 32 mgExperimentalSubjects received 32 mg of candesartan cilexetil (single capsule) monotherapy once daily for 8 weeks along with 3 placebo tablets
Receives: Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 32 mg
Nifedipine/candesartan 20/4 mgExperimentalSubjects received the combination of 20 mg of nifedipine GITS/4 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Candesartan cilexetil (Atacand), 4 mg; Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo
Nifedipine/candesartan 20/8 mgExperimentalSubjects received the combination of 20 mg of nifedipine GITS/8 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Candesartan cilexetil (Atacand), 8 mg; Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo
Nifedipine/candesartan 20/16 mgExperimentalSubjects received the combination of 20 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 20 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg
Nifedipine/candesartan 30/8 mgExperimentalSubjects received the combination of 30 mg of nifedipine GITS/8 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Candesartan cilexetil (Atacand), 8 mg; Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo
Nifedipine/candesartan 30/16 mgExperimentalSubjects received the combination of 30 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg
Nifedipine/candesartan 30/32 mgExperimentalSubjects received the combination of 30 mg of nifedipine GITS/32 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 30 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 32 mg
Nifedipine/candesartan 60/16 mgExperimentalSubjects received the combination of 60 mg of nifedipine GITS/16 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 60 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 16 mg
Nifedipine/candesartan 60/32 mgExperimentalSubjects received the combination of 60 mg of nifedipine GITS/32 mg of candesartan cilexetil once daily for 8 weeks along with 2 placebo tablets
Receives: Drug: Nifedipine GITS (Adalat, BAYA1040), 60 mg; Drug: Placebo; Drug: Candesartan cilexetil (Atacand), 32 mg
PlaceboPlacebo comparatorSubjects received placebo (3 tablets and 1 capsule) once daily for 8 weeks
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

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

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

Secondary outcomes (5)

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

    Measured: 8 weeks

  2. Control rate at Week 8

    Measured: 8 weeks

  3. Response rate at Week 8

    Measured: 8 weeks

  4. Peripheral Edema

    Measured: 8 weeks

  5. Time to achieve first BP control

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Feb 2011 (estimated)
  2. Study startApr 2011
  3. Primary completionMay 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,381 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01303783
Sponsor's protocol ID
14725
Other IDs
2009-017077-37, 2009
Acronym
DISTINCT
Status last verified
Apr 2017
First submitted
24 Feb 2011
Last updated
18 Apr 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26829251

  • 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.

    PubMed 25144296

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Candesartan cilexetil (Atacand), 4 mg, Candesartan cilexetil (Atacand), 8 mg and Nifedipine GITS (Adalat, BAYA1040), 20 mg in people with Hypertension, Essential, run by Bayer at 157 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 33 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, South Korea, United Kingdom, Canada, Argentina and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary efficacy variable is the change from baseline in mean seated diastolic blood pressure (MSDBP) at Week 8 (time frame: Baseline taken at Visit 1; primary outcome variable assesed at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01303783, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.

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