HypertensionPhase 1NCT01648231
Crossover Study to Evaluate the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine and Losartan in Health Volunteers
A Phase 1 study testing Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state, Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state and Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state in people with Hypertension, run by GlaxoSmithKline at 1 site in Australia.
Trial summary
The purpose of this study is to evaluate the comparative bioavailability of two fixed dose combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state, Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state and Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteAustralia
- Study dates
- 6 Aug 2012to 25 Sep 2012
- 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 or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Alanine transaminase (ALT), alkaline phosphatase and bilirubin ≤ 1.5 x upper limit of normal (ULN; isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Normal electrocardiogram (ECG) morphology and measurements. In particular QTc <450 msec or QT < 480 msec in subjects with Bundle Branch Block based on an average from three ECGs obtained over a brief recording period.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator feels that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures..
- A female subject is eligible to participate if she is of:
- Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal defined as 12 months of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous follicle stimulating hormone (FSH) > 40 MlU/ml and estradiol < 40 pg/ml (<147 pmol/L) is confirmatory. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use a protocol approved contraception method 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 enrollment. For mostforms of HRT, at least 2-4 weeks will elapse between the cessation of therapy and the blood draw; this interval depends on the type and dosage of HRT. Following confirmation of their post-menopausal status, they can resume use of HRT during the study without use of a contraceptive method.
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- Child-bearing potential and agrees to use one of the protocol approved contraception methods for an appropriate period of time (as determined by the product label or investigator) prior to the start of dosing to sufficiently minimize the risk of pregnancy at that point. Female subjects must agree to use contraception until 14 days post-last dose of amlodipine/losartan.
- Body weight ≥ 50 kg and a body mass index (BMI) within the range 19 - 32 kg/m2 (inclusive).
- Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
Who cannot join
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Any subject with a systolic blood pressure (BP) <95mmHg or with a recent history of postural symptoms.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
- History of regular alcohol consumption within 6 months of the study defined as:
Show all 21Show fewer
- An average weekly intake of >21 units for males or >14 units for females. One unit is equivalent to 8 g of alcohol: a half-pint (~240 ml) of beer, 1 glass (100 ml) of wine or 1 (25 ml) measure of spirits.
- The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 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
- Unable to refrain from the use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
- 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 GSK Medical Monitor, contraindicates their participation.
- Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
- Pregnant females as determined by positive urine human chorionic gonadotrophin (hCG) test at Day -1 or serum hCG at all other timepoints.
- Lactating females.
- Unwillingness or inability to follow the procedures outlined in the protocol.
- Subject is mentally or legally incapacitated.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Subjects who have asthma or a history of asthma
- Urinary cotinine levels indicative of smoking or history or regular use of tobacco- or nicotine-containing products within 6 months prior to screening.
- Positive carbon monoxide (CO) on admission to the Unit.
- Unable to refrain from consumption of red wine, seville oranges, grapefruit or grapefruit juice (and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices) from 7 days prior to the first dose of study medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Single Dose, Three-way Crossover Study to Determine the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine (5mg) and Losartan (100mg) in Healthy Adult Male and Female Subjects Under Fasting Conditions
The purpose of this study is to evaluate the comparative bioavailability of two fixed dose combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; all three treatments will be administered once orally and in a fasted state. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite). Safety assessments will include measurements of orthostatic vital signs, electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests.
Read the detailed description
Amlodipine and losartan are calcium channel and angiotensin II receptor type-1 blockers, respectively, and are established treatments to manage blood pressure (BP) levels for patients with hypertension; both medications are currently marketed in the United States and Europe as anti-hypertensive agents. This is a an open-label, randomized, single dose, three-way crossover study enrolling 24 healthy adult male and female subjects under fasting conditions. Each subject will participate in three treatment periods. The study consists of a screening phase, three treatment periods and a follow-up visit. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a single 5mg amlodipine tablet and a single 100mg losartan tablet; a single fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; and another single fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; all three treatments will be administered once orally and in a fasted state. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite). Safety assessments will include measurements of orthostatic vital signs, electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests.
- Conditions
- Hypertension
- Being tested
- Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state, Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state, Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
- Keywords
- Healthy Volunteer
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted stateDrug
Also called GSK2944406
1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state
Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted stateDrug
Also called GSK2944406
1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted stateDrug
Also called GSK2944406
1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state
| Study group | Role | What they receive |
|---|---|---|
| Treatment Period 1 | Other | 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state Receives: Drug: Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state |
| Treatment Period 2 | Other | 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state Receives: Drug: Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
| Treatment Period 3 | Other | 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state Receives: Drug: Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma concentration of amlodipine and losartan: Peak plasma concentration (Cmax) and last measurable plasma concentration (Clast)
Comparison of Cmax and Clast after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Time to peak plasma concentration (Tmax) of amlodipine and losartan
Comparison of Tmax after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Area under the plasma concentration-time curve (AUC) of amlodipine and losartan: from time zero to time t (AUCt), from time zero to infinity (AUCinf) and time t to infinity as a percentage of total AUC (%AUCex)
Comparison of AUCt, AUCinf and %AUCex after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Elimination half-life (t½) of amlodipine and losartan
Comparison of t½ after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Secondary outcomes (5)
Number of healthy volunteers with adverse events
Comparison of adverse events (as determined by orthostatic vital sign and electrocardiogram measurements and clinical lab results) after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the safety and tolerability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Plasma concentration of of carboxylic acid: Peak plasma concentration (Cmax)
Comparison of Cmax and Clast after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Elimination half-life (t½) of carboxylic acid
Comparison of t½ after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Time to peak plasma concentration (Tmax) of carboxylic acid
Comparison of Tmax after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Area under the plasma concentration-time curve (AUC) of carboxylic acid: from time zero to time t (AUCt), from time zero to infinity (AUCinf) and time t to infinity as a percentage of total AUC (%AUCex)
Comparison of AUCt, AUCinf and %AUCex after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Measured: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2012 (estimated)
- Study start6 Aug 2012
- Primary completion25 Sep 2012
- Study completion25 Sep 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01648231
- Sponsor's protocol ID
- 116797
- Status last verified
- Jul 2017
- First submitted
- 12 Jul 2012
- Last updated
- 26 Jul 2017
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Single Dose, Three-way Crossover Study to Determine the Comparative Bioavailability of Two Fixed Dose Combination Tablet Formulations of Amlodipine (5mg) and Losartan (100mg) in Healthy Adult Male and Female Subjects Under Fasting Conditions
- ClinicalTrials.gov ID
- NCT01648231
- Acronym / sponsor ID
- 116797
- Conditions
- Hypertension
- Keywords
- Healthy Volunteer
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 6 Aug 2012 (actual)
- Primary completion
- 25 Sep 2012 (actual)
- Study completion
- 25 Sep 2012 (actual)
- First posted
- 24 Jul 2012 (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.
The purpose of this study is to evaluate the comparative bioavailability of two fixed dose combination tablet formulations of amlodipine and losartan in healthy volunteers. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a 5mg amlodipine tablet and 100mg losartan tablet; a fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; and another fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; all three treatments will be administered once orally and in a fasted state. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite). Safety assessments will include measurements of orthostatic vital signs, electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests.
Detailed description
Amlodipine and losartan are calcium channel and angiotensin II receptor type-1 blockers, respectively, and are established treatments to manage blood pressure (BP) levels for patients with hypertension; both medications are currently marketed in the United States and Europe as anti-hypertensive agents. This is a an open-label, randomized, single dose, three-way crossover study enrolling 24 healthy adult male and female subjects under fasting conditions. Each subject will participate in three treatment periods. The study consists of a screening phase, three treatment periods and a follow-up visit. Subjects will receive each of the following three treatments administered in a randomized three-way crossover design: a reference treatment consisting of a single 5mg amlodipine tablet and a single 100mg losartan tablet; a single fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; and another single fixed dose combination tablet consisting of 5mg amlodipine and 100mg losartan; all three treatments will be administered once orally and in a fasted state. Serial blood samples will be obtained at pre-defined timepoints for pharmacokinetic analysis of amlodipine, losartan and carboxylic acid (this is the primary active losartan metabolite). Safety assessments will include measurements of orthostatic vital signs, electrocardiograms (ECG), collection of adverse events (AE) and clinical laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment Period 1 | Other | Drug: Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state |
| Treatment Period 2 | Other | Drug: Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
| Treatment Period 3 | Other | Drug: Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female between 18 and 65 years of age inclusive, at the time of signing the informed consent.
- Alanine transaminase (ALT), alkaline phosphatase and bilirubin ≤ 1.5 x upper limit of normal (ULN; isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- Normal electrocardiogram (ECG) morphology and measurements. In particular QTc <450 msec or QT < 480 msec in subjects with Bundle Branch Block based on an average from three ECGs obtained over a brief recording period.
- Healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, laboratory tests and cardiac monitoring. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the Investigator feels that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures..
- A female subject is eligible to participate if she is of:
Key exclusion criteria (21 listed)
- A positive pre-study Hepatitis B surface antigen or positive Hepatitis C antibody result within 3 months of screening.
- Any subject with a systolic blood pressure (BP) <95mmHg or with a recent history of postural symptoms.
- Current or chronic history of liver disease, or known hepatic or biliary abnormalities (with the exception of Gilbert's syndrome or asymptomatic gallstones).
- A positive pre-study drug/alcohol screen.
- A positive test for HIV antibody.
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 |
|---|---|---|
| Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted stateAlso: GSK29444061 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state | Drug | Treatment Period 1 |
| Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted stateAlso: GSK29444061 x 5mg amlodipine / 100mg losartan tablet administered in fasted state | Drug | Treatment Period 2 |
| Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted stateAlso: GSK29444061 x 5mg amlodipine / 100mg losartan tablet administered in fasted state | Drug | Treatment Period 3 |
Primary outcome
Plasma concentration of amlodipine and losartan: Peak plasma concentration (Cmax) and last measurable plasma concentration (Clast)
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Comparison of Cmax and Clast after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Time to peak plasma concentration (Tmax) of amlodipine and losartan
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Comparison of Tmax after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Area under the plasma concentration-time curve (AUC) of amlodipine and losartan: from time zero to time t (AUCt), from time zero to infinity (AUCinf) and time t to infinity as a percentage of total AUC (%AUCex)
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Comparison of AUCt, AUCinf and %AUCex after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
Elimination half-life (t½) of amlodipine and losartan
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Comparison of t½ after administration of two amlodipine and losartan fixed dose combinations in comparison to reference treatment (to determine the comparative bioavailability)
5 secondary outcomes
Number of healthy volunteers with adverse events
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Plasma concentration of of carboxylic acid: Peak plasma concentration (Cmax)
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Elimination half-life (t½) of carboxylic acid
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Time to peak plasma concentration (Tmax) of carboxylic acid
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
Area under the plasma concentration-time curve (AUC) of carboxylic acid: from time zero to time t (AUCt), from time zero to infinity (AUCinf) and time t to infinity as a percentage of total AUC (%AUCex)
Time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks
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 26 Jul 2017.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Results for study 116797 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 Reference Treatment: 1 x 5mg amlodipine tablet and 1 x 100mg losartan tablet administered in fasted state, Fixed Dose Combination 1: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state and Fixed Dose Combination 2: 1 x 5mg amlodipine / 100mg losartan tablet administered in fasted state in people with Hypertension, run by GlaxoSmithKline at 1 site in Australia.
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 9 inclusion and 21 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 26 Jul 2017. 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 Australia. 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?
Plasma concentration of amlodipine and losartan: Peak plasma concentration (Cmax) and last measurable plasma concentration (Clast) (time frame: Participants will be followed and monitored for the duration of their hospital stay (24 hours per treatment period). The longest duration of participation in the study will be approximately 14 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 26 Jul 2017.