Cardiovascular DiseasePhase 1NCT02254447

Relative Bioavailability Study of Candesartan Cilexetil Under Fasting Conditions

A Phase 1 study testing Candesartan Cilexetil in formulation 1, Candesartan Cilexetil in formulation 2 and ATACAND in people with Cardiovascular Disease, run by GlaxoSmithKline at 1 site in India.

Completed

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

Official record

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Trial summary

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Cardiovascular Disease
What is being tested?: Candesartan Cilexetil in formulation 1, Candesartan Cilexetil in formulation 2 and ATACAND
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 18 participants
Where: 1 siteIndia
Study dates: 2 Dec 2014to 8 Jan 2015
Phase: Phase 1
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 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >= 50 kilograms (kg) and Body Mass Index within the range 19 -24.9 kg/meter (m)^2 (inclusive).
Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies:
Non-reproductive potential defined as: Pre-menopausal females with documented tubal ligation, or documented hysteroscopic tubal occlusion procedure with follow-up confirmation of bilateral tubal occlusion, or hysterectomy, or documented bilateral oophorectomy.

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Postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone and estradiol levels consistent with menopause [refer to laboratory reference ranges for confirmatory levels]). Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the highly effective contraception methods if they wish to continue their HRT during the study. Otherwise, they must discontinue HRT to allow confirmation of post-menopausal status prior to study enrolment.
Reproductive potential and agrees to follow one of the options listed below in the GlaxoSmithKline (GSK) Modified List of Highly Effective Methods for Avoiding Pregnancy in Females of Reproductive Potential (FRP) requirements from 30 days prior to the first dose of study medication and until [at least five terminal half-lives OR until any continuing pharmacologic effect has ended, whichever is longer] after the last dose of study medication and completion of the follow-up visit.
GSK Modified List of Highly Effective Methods for Avoiding Pregnancy in FRP. This list does not apply to FRP with same sex partners, when this is their preferred and usual lifestyle or for subjects who are and will continue to be abstinent from penilevaginal intercourse on a long term and persistent basis:
Contraceptive subdermal implant that meets the effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
Intrauterine device or intrauterine system that meets the standard operating procedure (SOP) effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
Oral Contraceptive, either combined or progestogen alone. Injectable progestogen Contraceptive vaginal ring Percutaneous contraceptive patches Male partner sterilization with documentation of azoospermia prior to the female subject's entry into the study, and this male is the sole partner for that subject Male condom combined with a vaginal spermicide (foam, gel, film, cream, or suppository) only for the following 3 situations when there is a very low risk for developmental toxicity: Vaccines, Monoclonal antibodies when there is no target biology concern, Compounds that have a complete reproductive toxicology package and, have not shown any signal for developmental toxicity.
The investigator is responsible for ensuring that subjects understand how to properly use the following methods of contraception. Male subjects with female partners of child bearing potential must comply with the following contraception requirements from the time of first dose of study medication until [at least five half-lives of study medication OR for a cycle of spermatogenesis following five terminal half-lives] after the last dose of study medication: vasectomy with documentation of azoospermia, male condom plus partner use of one of the contraceptive options below:
Contraceptive subdermal implant that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label Intrauterine device or intrauterine system that meets the SOP effectiveness criteria including a <1% rate of failure per year, as stated in the product label.
Oral Contraceptive, either combined or progestogen alone Injectable progestogen Contraceptive vaginal ring Percutaneous contraceptive patches
Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.

Who cannot join

Alanine aminotransferase and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected (QTc) > 450 millisecond (msec).
No concomitant medications should be taken by the subject while participating in the study.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8grams of alcohol: a half-pint (equivalent to 240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.
Urinary cotinine levels indicative of smoking or history or regular use of tobacco or nicotine-containing products within 6 months prior to screening.

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History of sensitivity to heparin or heparin-induced thrombocytopenia.
History of sensitivity to any of the study medications, or components thereof or a history of drug or other allergy that, in the opinion of the investigator or Medical Monitor, contraindicates their participation.
Hypersensitivity to candesartan cilexetil or to any of the excipients.
Presence of hepatitis B surface antigen positive hepatitis C antibody test result at screening or within 3 months prior to first dose of study treatment. For potent immunosuppressive agents, subjects with presence of hepatitis B core.
A positive pre-study drug/alcohol screen.
A positive test for human immunodeficiency virus antibody.
Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 90 day period.
The subject has participated in a clinical trial and has received an investigational current study: 90 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
Gastrointestinal disease or with gastrointestinal surgical history which can affect the absorption of the investigational drug.
Any symptoms with a systolic blood pressure<95millimeter of mercury.
Pregnant females as determined by positive serum human chorionic gonadotrophin test at screening or prior to dosing.
Lactating females.

Trial locations and contacts

1 site in 1 country.

India1 site

GSK Investigational Site
Hyderabad, 500 013

Other trials in India

About this study

Official title: An Open-label, Randomized, Single Dose, Three-way Crossover, Six Sequence Pilot Study to Determine the Relative Bioavailability of Candesartan Cilexetil 16mg From Two Candidate Tablet Formulations of GW615775 Relative to One 16mg Tablet of Reference Candesartan Cilexetil in Healthy Adult Human Subjects Under Fasting Conditions

This study will investigate the relative bioavailability of two candidate tablet formulations of 16 milligram (mg) Candesartan cilexetil (GW615775) compared with the reference product ATACAND™ containing 16 mg Candesartan cilexetil in healthy human subjects. This is an open-label, randomized, single dose, three-way crossover, six sequence study enrolling 18 healthy human subjects to ensure at least 14 subjects complete the study as planned. Each subject enrolled will participate in all three treatment periods and will be assigned to one of the six treatment sequences, in accordance with the randomization schedule. The treatment periods will be separated by a washout period of at least 7 days and no more than 14 days between dosing occasions. A follow up visit will be conducted 14-21 days post last dosing. ATACAND is a registered trademark of the AstraZeneca group of companies.

Conditions: Cardiovascular Disease
Being tested: Candesartan Cilexetil in formulation 1, Candesartan Cilexetil in formulation 2, ATACAND
Keywords: relative bio-availability, fasting, GW615775, Candesartan cilexetil, ATACAND
Medical subject headings: Cardiovascular Diseases, Fasting

What participants receive

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

Candesartan Cilexetil in formulation 1Drug
Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
Candesartan Cilexetil in formulation 2Drug
Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration
ATACANDDrug
Round, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration

Study groups in NCT02254447
Study group	Role	What they receive
Sequence ABC	Experimental	Subjects in this arm will receive single dose of treatment A in period 1, treatment B in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. Receives: Drug: Candesartan Cilexetil in formulation 1; Drug: Candesartan Cilexetil in formulation 2; Drug: ATACAND
Sequence ACB	Experimental	Subjects in this arm will receive single dose of treatment A in period 1, treatment C in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. Receives: Drug: Candesartan Cilexetil in formulation 1; Drug: Candesartan Cilexetil in formulation 2; Drug: ATACAND
Sequence BAC	Experimental	Subjects in this arm will receive single dose of treatment B in period 1, treatment A in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. Receives: Drug: Candesartan Cilexetil in formulation 1; Drug: Candesartan Cilexetil in formulation 2; Drug: ATACAND
Sequence BCA	Experimental	Subjects in this arm will receive single dose of treatment B in period 1, treatment C in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. Receives: Drug: Candesartan Cilexetil in formulation 1; Drug: Candesartan Cilexetil in formulation 2; Drug: ATACAND
Sequence CAB	Experimental	Subjects in this arm will receive single dose of treatment C in period 1, treatment A in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. Receives: Drug: Candesartan Cilexetil in formulation 1; Drug: Candesartan Cilexetil in formulation 2; Drug: ATACAND
Sequence CBA	Experimental	Subjects in this arm will receive single dose of treatment C in period 1, treatment B in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg. Receives: Drug: Candesartan Cilexetil in formulation 1; Drug: Candesartan Cilexetil in formulation 2; Drug: ATACAND

What is being measured

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

Composite of pharmacokinetic (PK) parameters.
Pharmacokinetic parameters will be measured to estimate the relative bio-availability following administration of two candidate tablet formulations of Candesartan cilexetil relative to reference Candesartan cilexetil tablet. Pharmacokinetic parameters include: maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite]), Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC[0-t]).
Measured: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.

Secondary outcomes (4)

Plasma PK profile
Pharmacokinetic parameters to be estimated include: time of occurrence of Cmax (Tmax), terminal phase half-life (t1/2) and percentage of AUC(0-infinity) obtained by extrapolation (%AUCex).
Measured: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.
Vital sign assessment as a safety measure
Vital sign assessment include: blood pressure and pulse rate measurements.
Measured: Up to 30 days
Number of subjects with adverse events as a safety measure
Adverse events will be collected from the start of Study Treatment until the subject's final discharge from study at the end of Treatment Period 3, follow-up call or last outpatient visit, whichever is the latest.
Measured: 50 days
Laboratory parameter assessment as a safety measure
Laboratory parameters include: hematology, clinical chemistry, urinalysis and additional parameters.
Measured: Up to 30 days

Timeline

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

2 Dec 20148 Jan 2015

First posted1 Oct 2014 (estimated)
Study start2 Dec 2014
Primary completion8 Jan 2015
Study completion8 Jan 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 1
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 18 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02254447
Sponsor's protocol ID: 201713
Status last verified: Mar 2018
First submitted: 29 Sep 2014
Last updated: 12 Mar 2018
Results posted: No
Data monitoring committee: No
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 12 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-label, Randomized, Single Dose, Three-way Crossover, Six Sequence Pilot Study to Determine the Relative Bioavailability of Candesartan Cilexetil 16mg From Two Candidate Tablet Formulations of GW615775 Relative to One 16mg Tablet of Reference Candesartan Cilexetil in Healthy Adult Human Subjects Under Fasting Conditions
ClinicalTrials.gov ID: NCT02254447
Acronym / sponsor ID: 201713
Conditions: Cardiovascular Disease
Keywords: relative bio-availability, fasting, GW615775, Candesartan cilexetil, ATACAND
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 18 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 2 Dec 2014 (actual)
Primary completion: 8 Jan 2015 (actual)
Study completion: 8 Jan 2015 (actual)
First posted: 1 Oct 2014 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 6

Arm	Type	Receives
Sequence ABC	Experimental	Drug: Candesartan Cilexetil in formulation 1, Drug: Candesartan Cilexetil in formulation 2, Drug: ATACANDSubjects in this arm will receive single dose of treatment A in period 1, treatment B in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
Sequence ACB	Experimental	Drug: Candesartan Cilexetil in formulation 1, Drug: Candesartan Cilexetil in formulation 2, Drug: ATACANDSubjects in this arm will receive single dose of treatment A in period 1, treatment C in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
Sequence BAC	Experimental	Drug: Candesartan Cilexetil in formulation 1, Drug: Candesartan Cilexetil in formulation 2, Drug: ATACANDSubjects in this arm will receive single dose of treatment B in period 1, treatment A in period 2 and treatment C in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
Sequence BCA	Experimental	Drug: Candesartan Cilexetil in formulation 1, Drug: Candesartan Cilexetil in formulation 2, Drug: ATACANDSubjects in this arm will receive single dose of treatment B in period 1, treatment C in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
Sequence CAB	Experimental	Drug: Candesartan Cilexetil in formulation 1, Drug: Candesartan Cilexetil in formulation 2, Drug: ATACANDSubjects in this arm will receive single dose of treatment C in period 1, treatment A in period 2 and treatment B in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.
Sequence CBA	Experimental	Drug: Candesartan Cilexetil in formulation 1, Drug: Candesartan Cilexetil in formulation 2, Drug: ATACANDSubjects in this arm will receive single dose of treatment C in period 1, treatment B in period 2 and treatment A in period 3 (one treatment per period), where treatment A= ATACAND as a reference treatment containing Candesartan cilexetil 16 mg, treatment B= Test formulation 1 containing Candesartan cilexetil 16 mg, and treatment C= Test formulation 2 containing Candesartan cilexetil 16 mg.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (16 listed)

Male and females aged between 18 and 65 years of age inclusive, at the time of signing the informed consent.
Healthy as determined by the investigator or medically qualified designee based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring.
A subject with a clinical abnormality or laboratory parameter(s) which is/are not specifically listed in the inclusion or exclusion criteria, outside the reference range for the population being studied may be included only if the investigator in consultation with the Medical Monitor if required, agree and document that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
Body weight >= 50 kilograms (kg) and Body Mass Index within the range 19 -24.9 kg/meter (m)^2 (inclusive).
Female subject: is eligible to participate if she is not pregnant (as confirmed by a negative serum human chorionic gonadotrophin test), not lactating, and at least one of the following conditions applies:

Key exclusion criteria (19 listed)

Alanine aminotransferase and bilirubin >1.5x upper limit of normal (ULN) (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%).
Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
QT interval corrected (QTc) > 450 millisecond (msec).
No concomitant medications should be taken by the subject while participating in the study.
History of regular alcohol consumption within 6 months of the study defined as an average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8grams of alcohol: a half-pint (equivalent to 240 milliliter [mL]) of beer, 1 glass (125 mL) of wine or 1 (25 mL) measure of spirits.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Candesartan Cilexetil in formulation 1Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
Candesartan Cilexetil in formulation 2Round, biconvex white tablets containing Candesartan cilexetil 16 mg for oral administration	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA
ATACANDRound, biconvex pink tablets containing Candesartan cilexetil 16 mg for oral administration	Drug	Sequence ABC, Sequence ACB, Sequence BAC, Sequence BCA, Sequence CAB, Sequence CBA

Primary outcome

Composite of pharmacokinetic (PK) parameters.
Time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.
Pharmacokinetic parameters will be measured to estimate the relative bio-availability following administration of two candidate tablet formulations of Candesartan cilexetil relative to reference Candesartan cilexetil tablet. Pharmacokinetic parameters include: maximum observed concentration (Cmax), area under the concentration-time curve from time zero (pre-dose) extrapolated to infinite time (AUC[0-infinite]), Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration within a subject across all treatments (AUC[0-t]).

4 secondary outcomes

Plasma PK profile
Time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.
Vital sign assessment as a safety measure
Time frame: Up to 30 days
Number of subjects with adverse events as a safety measure
Time frame: 50 days
Laboratory parameter assessment as a safety measure
Time frame: Up to 30 days

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2018.
Results for study 201713 can be found on the GSK Clinical Study Register.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Candesartan Cilexetil in formulation 1, Candesartan Cilexetil in formulation 2 and ATACAND in people with Cardiovascular Disease, run by GlaxoSmithKline at 1 site in India.

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 16 inclusion and 19 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 12 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in India. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

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?

Composite of pharmacokinetic (PK) parameters. (time frame: PK samples will be collected at pre-dose, 0.5, 1, 1.5, 2, 2.5, 3.0, 3.5, 4.0, 4.5, 5.0, 5.5, 6.0, 7.0, 8.0, 10.0, 12.0, 16.0, 24, 36 and 48 hours post dose in each treatment period.). 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 NCT02254447.

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 12 Mar 2018.