HypertensionPhase 3NCT02172040
Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
A Phase 3 study testing Over-encapsulated 10 mg amlodipine besylate tablet and Over-encapsulated 200 mg celecoxib capsule in people with Hypertension, run by Kitov Pharmaceuticals, Ltd. at 10 sites in United Kingdom.
Trial summary
The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate in subjects with newly diagnosed hypertension requiring antihypertensive therapy. This study was conducted to support a future marketing application for KIT-302. Kitov Pharma Ltd. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Over-encapsulated 10 mg amlodipine besylate tablet and Over-encapsulated 200 mg celecoxib capsule
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 152 participants
- Where
- 10 sitesUnited Kingdom
- Study dates
- 26 Jun 2014to 19 Nov 2015
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult 40 to 75 years of age
- Newly diagnosed hypertension that requires chronic pharmacological therapy. Specifically, the subject must meet both of the following criteria:
- Resting systolic BP ≥140 mmHg and ≤179 mmHg (where resting is defined as supine for at least 10 minutes with minimal interaction) at Initial Screening Visit
- SBPday >135 mmHg at Baseline Visit (Day 0)
- Body Mass Index of 18.5 to 34.9 kg/m2
- Healthy (other than hypertension) as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests
Show all 9Show fewer
- A negative pregnancy test at Screening
- Both males and women of child bearing potential agree to use adequate contraceptive methods while on study (from Screening through final study visit)
- Able to comprehend and sign an informed consent form
Who cannot join
- Resting systolic BP >179 mmHg or a resting diastolic BP >110 mmHg at Screening (where resting is defined as supine for at least 10 minutes with minimal interaction) or SBP24h >169 mmHg or DBP24h >110 mmHg at randomization
- SBPday ≤135 mmHg at baseline (Day 0)
- Weight <55 kg
- Fragile health
- Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of safety data
- Current or recent history (within 4 weeks prior to Screening) of a clinically significant bacterial, fungal, or mycobacterial infection
Show all 31Show fewer
- Current clinically significant viral infection
- History of malignancy, with the exception of cured basal cell or squamous cell carcinoma of the skin
- Major surgery within 4 weeks prior to Screening
- Presence of a malabsorption syndrome possibly affecting drug absorption (e.g., Crohn's disease or chronic pancreatitis)
- Active peptic ulceration or history of gastrointestinal bleeding
- History of myocardial infarction, congestive heart failure, or stroke
- Any current cardiovascular disease
- History of psychotic disorder
- History of alcoholism or drug addiction or current alcohol or drug use that, in the opinion of the Investigator, will interfere with the subject's ability to comply with the dosing schedule and study evaluations
- History of any illicit drug use within one year prior to Screening
- Positive drug screen at Screening. A positive drug screen for opiates only (with all other drug tests negative) will not be a basis for exclusion if the subject took over-the-counter narcotics as indicated on the product label within 24 hours prior to the drug screen
- Current treatment or treatment within 30 days prior to first dose of study drugs with another investigational drug or current enrollment in another clinical trial
- Current treatment or treatment within 30 days prior to first dose of study drugs with an NSAID or systemic corticosteroid
- Known history of human immunodeficiency virus, hepatitis B, or hepatitis C
- Known hypersensitivity to amlodipine or celecoxib
- Known hypersensitivity to the inactive ingredients in the over-encapsulated study drugs
- Asthma, acute rhinitis, nasal polyps, angioneurotic oedema, urticaria or other allergic type reactions after taking acetylsalicylic acid or NSAIDs including cyclooxygenase-2 inhibitors
- Subjects who, in the opinion of the Investigator, are unable or unlikely to comply with the dosing schedule and study evaluations
- Pregnant or lactating
- Unable to correctly use ambulatory blood pressure monitor after instruction on its use
- Subjects with Child-Pugh Class B or C cirrhosis;
- Subjects currently taking a calcium channel blocker for any reason including angina. Subjects will not be withdrawn from these drugs to be enrolled in the trial
- Creatinine clearance <50 ml/min as estimated by the Cockroft-Gault equation
- Known cytochrome P450 2C9 poor metabolizer
- Subjects with allergy or hypersensitivity to sulfonamides
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United Kingdom10 sites
Oldfield Surgery
Bath, North East Somerset, BA2 3HT
Celerion
Belfast, Antrim, BT9 6AD
Synexus Midlands Clinical Research Centre
Birmingham, B15 2SQ
Rowden Surgery
Chippenham, Wiltshire, SN15 2SB
Synexus Scotland Clinical Research Centre
Glasgow, G20 0SP
Reading Clinical Research Aspect
Ledbury, Herefordshire, HR8 2AA
Synexus Merseyside Clinical Research Centre
Liverpool, Merseyside, L22 0LG
Barts Health NHS Trust, William Harvey Heart Centre, Barts & The London, Queen Mary School of Medicine and Dentistry, Queen Mary, University of London
London, EC1M 6BQ
The Medicines Evaluation Unit Ltd.
Manchester, Greater Manchester, M23 9QZ
Reading Clinical Research Aspect
Reading, RG6 6BZ
About this study
Official title: A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
The purpose of this study was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate in subjects with newly diagnosed hypertension requiring antihypertensive therapy.
This study was conducted to support a future marketing application for KIT-302. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib.
Read more
The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study, two separate capsules were utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched placebo tablet.
The study hypothesis was that treatment with the amlodipine besylate containing capsule plus the celecoxib containing capsule would reduce blood pressure (BP) in subjects with hypertension with an efficacy that is not substantially inferior to the effect of amlodipine besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the celecoxib capsule).
The United States (US) Food and Drug Administration (FDA) recently approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
- Conditions
- Hypertension
- Being tested
- Over-encapsulated 10 mg amlodipine besylate tablet, Matched placebo capsule for over-encapsulated celecoxib capsule, Over-encapsulated 200 mg celecoxib capsule, Matched placebo capsule for over-encapsulated amlodipine besylate tablet
- Keywords
- High blood pressure, Systolic blood pressure, Diastolic blood pressure, Antihypertensive
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Over-encapsulated 10 mg amlodipine besylate tabletDrug
Also called Norvasc
Over-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks
Matched placebo capsule for over-encapsulated celecoxib capsuleDrug
Also called Placebo
Matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks
Over-encapsulated 200 mg celecoxib capsuleDrug
Also called Celebrex
Over-encapsulated 200 mg celecoxib capsule once a day for two weeks
Matched placebo capsule for over-encapsulated amlodipine besylate tabletDrug
Also called Placebo
Matched placebo capsule for over-encapsulated amlodipine besylate tablet once a day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine+Celecoxib | Experimental | Over-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Receives: Drug: Over-encapsulated 10 mg amlodipine besylate tablet; Drug: Over-encapsulated 200 mg celecoxib capsule |
| Amlodipine+Placebo | Active comparator | Over-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Receives: Drug: Over-encapsulated 10 mg amlodipine besylate tablet; Drug: Matched placebo capsule for over-encapsulated celecoxib capsule |
| Placebo+Celecoxib | Placebo comparator | Matched placebo capsule for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks Receives: Drug: Over-encapsulated 200 mg celecoxib capsule; Drug: Matched placebo capsule for over-encapsulated amlodipine besylate tablet |
| Placebo+Placebo | Sham comparator | Matched placebo capsule for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks Receives: Drug: Matched placebo capsule for over-encapsulated celecoxib capsule; Drug: Matched placebo capsule for over-encapsulated amlodipine besylate tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint
Measured: Baseline and 2 weeks
Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk)
Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug [i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug].
Measured: 1 month
Secondary outcomes (10)
Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)
Measured: Baseline and 2 weeks
Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight)
Measured: Baseline and 2 weeks
Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)
Measured: Baseline and 2 weeks
Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday)
Measured: Baseline and 2 weeks
Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight)
Measured: Baseline and 2 weeks
Mean Non-transformed Amlodipine Plasma Concentration
Measured: 24 hours post-dose on Day 14
Mean Non-transformed Celecoxib Plasma Concentration
Measured: 24 hours post-dose on Day 14
Mean Log-transformed Amlodipine Plasma Concentration
Measured: 24 hours post-dose on Day 14
Mean Log-transformed Celecoxib Plasma Concentration
Measured: 24 hours post-dose on Day 14
Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint
Measured: Baseline and 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2014 (estimated)
- Study start26 Jun 2014
- Primary completion19 Nov 2015
- Study completion19 Nov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kitov Pharmaceuticals, Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- J. Paul Waymack, MD, ScD, Study director, Kitov Pharma LtdBrendan Colgan, MD, Principal investigator, CelerionClaire Kightley, MB, Principal investigator, Reading Clinical Research AspectDavid Collier, MBBS, PhD, BSc, Principal investigator, Barts Health NHS Trust, William Harvey Heart Centre, Barts & The London, Queen Mary School of Medicine and Dentistry, Queen Mary, University of LondonPaul Ivan, MBBS, Principal investigator, Synexus Merseyside Clinical Research CentreVeronika Horvathova, MD, Principal investigator, Synexus Scotland Clinical Research CentreAmit Mathew, MS, MBBS, Principal investigator, Synexus Midlands Clinical Research CentreAlexander Thompson, MB, BS, DRCOG, Principal investigator, Reading Clinical Research Aspect
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02172040
- Sponsor's protocol ID
- KIT-302-03-01
- Other IDs
- 2013-005381-19
- Status last verified
- Sep 2018
- First submitted
- 20 Jun 2014
- Last updated
- 10 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Placebo Controlled Study to Evaluate the Effect of Celecoxib on the Efficacy and Safety of Amlodipine in Subjects With Hypertension Requiring Antihypertensive Therapy
- ClinicalTrials.gov ID
- NCT02172040
- Acronym / sponsor ID
- KIT-302-03-01
- Conditions
- Hypertension
- Keywords
- High blood pressure, Systolic blood pressure, Diastolic blood pressure, Antihypertensive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 152 participants (actual)
- Lead sponsor
- Kitov Pharmaceuticals, Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2014 (actual)
- Primary completion
- 19 Nov 2015 (actual)
- Study completion
- 19 Nov 2015 (actual)
- First posted
- 24 Jun 2014 (estimated)
- Results
- Posted 3 Oct 2017
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 was to evaluate the effect of celecoxib on the efficacy and safety of amlodipine besylate in subjects with newly diagnosed hypertension requiring antihypertensive therapy.
This study was conducted to support a future marketing application for KIT-302. Kitov Pharma Ltd. (Kitov) is developing KIT-302, an oral fixed combination drug product (FCDP) consisting of the calcium channel blocker amlodipine besylate and the nonsteroidal anti-inflammatory drug (NSAID) celecoxib, as a "convenience reformulation" FCDP to facilitate and improve patient compliance with the once a day (qd) administration of its individual components, amlodipine and celecoxib.
The formulation of KIT-302 consists of amlodipine besylate and celecoxib co-formulated in a single immediate release tablet. However, for this study, two separate capsules were utilized: one containing a commercial celecoxib capsule (Celebrex®) or matched placebo capsule and one containing a commercial amlodipine besylate tablet (Norvasc®) or matched placebo tablet.
The study hypothesis was that treatment with the amlodipine besylate containing capsule plus the celecoxib containing capsule would reduce blood pressure (BP) in subjects with hypertension with an efficacy that is not substantially inferior to the effect of amlodipine besylate alone (i.e., the amlodipine containing capsule plus the matched placebo for the celecoxib capsule).
The United States (US) Food and Drug Administration (FDA) recently approved KIT-302, under the brand name Consensi® (amlodipine and celecoxib) tablets [New Drug Application (NDA) 210045] for the following indication: "patients for whom treatment with amlodipine for hypertension and celecoxib for osteoarthritis are appropriate. Lowering blood pressure reduces the risk of fatal and nonfatal cardiovascular events, primarily strokes and myocardial infarctions."
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Amlodipine+Celecoxib | Experimental | Drug: Over-encapsulated 10 mg amlodipine besylate tablet, Drug: Over-encapsulated 200 mg celecoxib capsuleOver-encapsulated 10 mg amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Amlodipine+Placebo | Active comparator | Drug: Over-encapsulated 10 mg amlodipine besylate tablet, Drug: Matched placebo capsule for over-encapsulated celecoxib capsuleOver-encapsulated 10 mg amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
| Placebo+Celecoxib | Placebo comparator | Drug: Over-encapsulated 200 mg celecoxib capsule, Drug: Matched placebo capsule for over-encapsulated amlodipine besylate tabletMatched placebo capsule for over-encapsulated amlodipine besylate tablet + over-encapsulated 200 mg celecoxib capsule once a day for two weeks |
| Placebo+Placebo | Sham comparator | Drug: Matched placebo capsule for over-encapsulated celecoxib capsule, Drug: Matched placebo capsule for over-encapsulated amlodipine besylate tabletMatched placebo capsule for over-encapsulated amlodipine besylate tablet + matched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult 40 to 75 years of age
- Newly diagnosed hypertension that requires chronic pharmacological therapy. Specifically, the subject must meet both of the following criteria:
- Body Mass Index of 18.5 to 34.9 kg/m2
- Healthy (other than hypertension) as determined by the Investigator based on medical history, physical examination, vital signs, 12-lead electrocardiogram (ECG), and clinical laboratory tests
- A negative pregnancy test at Screening
Key exclusion criteria (31 listed)
- Resting systolic BP >179 mmHg or a resting diastolic BP >110 mmHg at Screening (where resting is defined as supine for at least 10 minutes with minimal interaction) or SBP24h >169 mmHg or DBP24h >110 mmHg at randomization
- SBPday ≤135 mmHg at baseline (Day 0)
- Weight <55 kg
- Fragile health
- Evidence of clinically significant findings on screening evaluations (clinical, laboratory, and ECG) which, in the opinion of the Investigator would pose a safety risk or interfere with appropriate interpretation of safety data
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 |
|---|---|---|
| Over-encapsulated 10 mg amlodipine besylate tabletAlso: NorvascOver-encapsulated 10 mg amlodipine besylate tablet once a day for two weeks | Drug | Amlodipine+Celecoxib, Amlodipine+Placebo |
| Matched placebo capsule for over-encapsulated celecoxib capsuleAlso: PlaceboMatched placebo capsule for over-encapsulated celecoxib capsule once a day for two weeks | Drug | Amlodipine+Placebo, Placebo+Placebo |
| Over-encapsulated 200 mg celecoxib capsuleAlso: CelebrexOver-encapsulated 200 mg celecoxib capsule once a day for two weeks | Drug | Amlodipine+Celecoxib, Placebo+Celecoxib |
| Matched placebo capsule for over-encapsulated amlodipine besylate tabletAlso: PlaceboMatched placebo capsule for over-encapsulated amlodipine besylate tablet once a day for two weeks | Drug | Placebo+Celecoxib, Placebo+Placebo |
Primary outcome
Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint
Time frame: Baseline and 2 weeks
Frequency of Adverse Events (Number of Participants Affected/Number of Participants at Risk)
Time frame: 1 month
Including any untoward medical occurrence in a participant administered study drug, which do not necessarily have a causal relationship with the study drug [i.e., any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of the study drug, whether or not related to the study drug].
10 secondary outcomes
Mean Change in Average 24-hour Ambulatory Systolic Blood Pressure (SBP24h)
Time frame: Baseline and 2 weeks
Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Systolic Blood Pressure (SBPnight)
Time frame: Baseline and 2 weeks
Mean Change in Average 24-hour Ambulatory Diastolic Blood Pressure (DBP24h)
Time frame: Baseline and 2 weeks
Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Diastolic Blood Pressure (DBPday)
Time frame: Baseline and 2 weeks
Mean Change in Average Night-time (01:00 to 06:00) Ambulatory Diastolic Blood Pressure (DBPnight)
Time frame: Baseline and 2 weeks
Mean Non-transformed Amlodipine Plasma Concentration
Time frame: 24 hours post-dose on Day 14
Mean Non-transformed Celecoxib Plasma Concentration
Time frame: 24 hours post-dose on Day 14
Mean Log-transformed Amlodipine Plasma Concentration
Time frame: 24 hours post-dose on Day 14
Mean Log-transformed Celecoxib Plasma Concentration
Time frame: 24 hours post-dose on Day 14
Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Secondary Endpoint
Time frame: Baseline and 2 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
J. Paul Waymack, MD, ScD study director
Kitov Pharma Ltd
Brendan Colgan, MD principal investigator
Celerion
Claire Kightley, MB principal investigator
Reading Clinical Research Aspect
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Over-encapsulated 10 mg amlodipine besylate tablet and Over-encapsulated 200 mg celecoxib capsule in people with Hypertension, run by Kitov Pharmaceuticals, Ltd. at 10 sites in United Kingdom.
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 31 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 10 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United Kingdom. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Change in Average Daytime (9:00 to 21:00) Ambulatory Systolic Blood Pressure (SBPday) - Primary Endpoint (time frame: Baseline and 2 weeks). The study lists 2 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 10 Oct 2018.