Essential HypertensionPhase 1NCT01900171
Phase I Study in Healthy Male Subjects Comparing QGC001 to Placebo
A Phase 1 study testing QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] in people with Essential Hypertension, run by Quantum Genomics SA at 1 site in France.
Trial summary
QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension
- What is being tested?
- QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to May 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 45 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Caucasian, male healthy subjects of 18 to 45 years of age.
- Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
- Subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
- Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings.
- Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
- Have a high probability for compliance with and completion of the study.
Who cannot join
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
- Acute disease state within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
- Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
- Positive findings of urine drug screen (e.g., amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA)
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- History of any clinically important drug allergy.
- Prohibited Treatments: use of any investigational drug within 90 days or prescription drug within 30 days before investigational medical product administration.
- Consumption of any caffeine-containing products in excess of 6 cups per day (or equivalent), of grapefruit, grapefruit-containing products, or alcoholic beverages within 24 hours before study day 1.
- Use of any over-the-counter drugs including herbal supplements (except for the occasional use of acetaminophen [paracetamol], aspirin and vitamins ≤100% recommended daily allowance) within 7 days before investigational medicinal product administration.
- Donation of blood (i.e. 450 ml) within 90 days before study day 1.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Double-blind, Placebo-controlled, Ascending Single-dose, Safety, Tolerability and Pharmacokinetic Study of QGC001 in Healthy Male Subjects.
QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.
- Conditions
- Essential Hypertension
- Being tested
- QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)], Placebo
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Drug
PlaceboDrug
Contains magnesium stearate, silica dental type, anhydrous lactose
| Study group | Role | What they receive |
|---|---|---|
| 10 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 50 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 125 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 250 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 500 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 750 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 1,000 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| 1,250 mg of QGC001 | Experimental | Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] |
| Placebo | Placebo comparator | The placebo was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events
Measured: up to 11 days
Blood pressure
Measured: up to 11 days
Heart rate
Measured: up to 11 days
Body temperature
Measured: up to 11 days
12-lead ECG
Measured: up to 11 days
Red blood cell count
Measured: up to 11 days
Haemoglobin
Measured: up to 11 days
Haematocrit
Measured: up to 11 days
White blood cell count with differential
Measured: up to 11 days
Platelet count
Measured: up to 11 days
Plasma sodium
Measured: up to 11 days
Plasma potassium
Measured: up to 11 days
Plasma calcium
Measured: up to 11 days
Plasma total bilirubin
Measured: up to 11 days
Plasma conjugated bilirubin
Measured: up to 11 days
Plasma Aspartate Amino Transferase (ASAT)
Measured: up to 11 days
Plasma Alanine Amino Transferase (ALAT)
Measured: up to 11 days
Plasma Gamma Glutamyl Transferase (GGT)
Measured: up to 11 days
Plasma alkaline phosphatases
Measured: up to 11 days
Plasma total protein
Measured: up to 11 days
Plasma Creatine PhosphoKinase (CPK)
Measured: up to 11 days
Plasma creatinine
Measured: up to 11 days
Plasma glucose
Measured: up to 11 days
Plasma cholesterol
Measured: up to 11 days
Plasma triglycerides
Measured: up to 11 days
Urinary pH
Measured: up to 11 days
Urinary protein
Measured: up to 11 days
Urinary glucose
Measured: up to 11 days
Urinary leukocytes
Measured: up to 11 days
Urinary nitrites
Measured: up to 11 days
Urinary ketones
Measured: up to 11 days
Urinary blood
Measured: up to 11 days
Secondary outcomes (17)
Maximum observed plasma concentration (Cmax) of QGC001
Measured: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Time at which Cmax is observed (tmax) of QGC001
Measured: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Elimination rate constant (λz) of QGC001
Measured: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Terminal half-life (t1/2,z) of QGC001
Measured: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Area Under the Concentration-time curve (AUClast and AUC0-∞) of QGC001
Measured: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Maximum observed plasma concentration (MRCmax) of metabolic ratios
Measured: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Area Under the Concentration-time curve (MRAUC) of metabolic ratios
Measured: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Cumulative amount eliminated (Ae)
Measured: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Fraction recovered (Fe)
Measured: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Renal clearance (CLR)
Measured: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Plasma renin
Determination of renin in blood samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
Measured: H-1 pre-dose and H2, H4 and H9 post-dose
Plasma aldosterone
Determination of aldosterone in blood samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
Measured: H-1 pre-dose and H2, H4 and H9 post-dose
Plasma cortisol
Determination of cortisol in blood samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
Measured: H-1 pre-dose and H2, H4 and H9 post-dose
Plasma copeptin
Determination of copeptin in blood samples (if possible, will be determined later). In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
Measured: H-1 pre-dose and H2, H4 and H9 post-dose
Urinary aldosterone
Aldosterone analysis in urine samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
Measured: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Urinary cortisol
Cortisol analysis in urine samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
Measured: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Urinary creatinin
Creatinin analysis in urine samples. In dose groups 1 and 2, no pharmacodynamic evaluations will be done.
Measured: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2013 (estimated)
- Study startFeb 2012
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Essential 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 1
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Quantum Genomics SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900171
- Sponsor's protocol ID
- QGC001/1QG1
- Status last verified
- Jul 2013
- First submitted
- 26 Jun 2013
- Last updated
- 16 Jul 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
PubMed 33027067
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Double-blind, Placebo-controlled, Ascending Single-dose, Safety, Tolerability and Pharmacokinetic Study of QGC001 in Healthy Male Subjects.
- ClinicalTrials.gov ID
- NCT01900171
- Acronym / sponsor ID
- QGC001/1QG1
- Conditions
- Essential Hypertension
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Quantum Genomics SAIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 16 Jul 2013 (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.
QGC001/1QG1 is a Phase I "first time in man" study aiming to determine the overall safety and tolerability of single ascending oral doses of QGC001 in healthy male subjects compared to placebo, as well as the pharmacokinetics of QGC001 and its metabolite EC33 and the pharmacodynamic properties of QGC001 (effects on the renin-angiotensin-aldosterone system, blood pressure and heart rate) in healthy male subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| 10 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| 50 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| 125 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| 250 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| 500 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| 750 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| 1,000 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| 1,250 mg of QGC001 | Experimental | Drug: QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)]Each dose of QGC001 was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
| Placebo | Placebo comparator | Drug: PlaceboThe placebo was administered orally with 100 mL of sterile water for irrigation at 08:00 in the morning of Day 1. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Caucasian, male healthy subjects of 18 to 45 years of age.
- Body weight ≥50 kg, with a body mass index calculated as weight in kg/(height in m2) from 18 to 27 kg/m2 at screening.
- Subjects will sign and date an informed consent form before any study-specific screening procedure is performed.
- Healthy, as determined by the investigator on the basis of medical history, physical examination findings, clinical laboratory test results, vital sign measurements, and digital 12 lead ECG readings.
- Non-smoker or smoker of fewer than 5 cigarettes per day as determined by history. Must be able to abstain from smoking during the inpatient stay.
Key exclusion criteria (11 listed)
- Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatological, haematological, neurologic, psychiatric disease or history of any clinically important drug allergy.
- Acute disease state within 7 days before study day 1.
- History of drug abuse within 1 year before study day 1.
- History of alcoholism within 1 year before day 1. Consumption of more than 50 g of ethanol per day.
- Positive serologic findings for human immunodeficiency virus antibodies, hepatitis B surface antigen, and/or hepatitis C virus antibodies.
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 |
|---|---|---|
| QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] | Drug | 1,000 mg of QGC001, 1,250 mg of QGC001, 10 mg of QGC001, 125 mg of QGC001, 250 mg of QGC001, 50 mg of QGC001, 500 mg of QGC001, 750 mg of QGC001 |
| PlaceboContains magnesium stearate, silica dental type, anhydrous lactose | Drug | Placebo |
Primary outcome
Adverse events
Time frame: up to 11 days
Blood pressure
Time frame: up to 11 days
Heart rate
Time frame: up to 11 days
Body temperature
Time frame: up to 11 days
12-lead ECG
Time frame: up to 11 days
Red blood cell count
Time frame: up to 11 days
Haemoglobin
Time frame: up to 11 days
Haematocrit
Time frame: up to 11 days
White blood cell count with differential
Time frame: up to 11 days
Platelet count
Time frame: up to 11 days
Plasma sodium
Time frame: up to 11 days
Plasma potassium
Time frame: up to 11 days
Plasma calcium
Time frame: up to 11 days
Plasma total bilirubin
Time frame: up to 11 days
Plasma conjugated bilirubin
Time frame: up to 11 days
Plasma Aspartate Amino Transferase (ASAT)
Time frame: up to 11 days
Plasma Alanine Amino Transferase (ALAT)
Time frame: up to 11 days
Plasma Gamma Glutamyl Transferase (GGT)
Time frame: up to 11 days
Plasma alkaline phosphatases
Time frame: up to 11 days
Plasma total protein
Time frame: up to 11 days
Plasma Creatine PhosphoKinase (CPK)
Time frame: up to 11 days
Plasma creatinine
Time frame: up to 11 days
Plasma glucose
Time frame: up to 11 days
Plasma cholesterol
Time frame: up to 11 days
Plasma triglycerides
Time frame: up to 11 days
Urinary pH
Time frame: up to 11 days
Urinary protein
Time frame: up to 11 days
Urinary glucose
Time frame: up to 11 days
Urinary leukocytes
Time frame: up to 11 days
Urinary nitrites
Time frame: up to 11 days
Urinary ketones
Time frame: up to 11 days
Urinary blood
Time frame: up to 11 days
17 secondary outcomes
Maximum observed plasma concentration (Cmax) of QGC001
Time frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Time at which Cmax is observed (tmax) of QGC001
Time frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Elimination rate constant (λz) of QGC001
Time frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Terminal half-life (t1/2,z) of QGC001
Time frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Area Under the Concentration-time curve (AUClast and AUC0-∞) of QGC001
Time frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Maximum observed plasma concentration (MRCmax) of metabolic ratios
Time frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Area Under the Concentration-time curve (MRAUC) of metabolic ratios
Time frame: H0, H 0.5, H1, H1.5, H2, H3, H4, H5, H6, H9, H12, H24 and H48 post-dose
Cumulative amount eliminated (Ae)
Time frame: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Fraction recovered (Fe)
Time frame: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Renal clearance (CLR)
Time frame: H-12 to H0 pre-dose and H0- H6, H6-H12 and H12-H24 post-dose
Plasma renin
Time frame: H-1 pre-dose and H2, H4 and H9 post-dose
Plasma aldosterone
Time frame: H-1 pre-dose and H2, H4 and H9 post-dose
Plasma cortisol
Time frame: H-1 pre-dose and H2, H4 and H9 post-dose
Plasma copeptin
Time frame: H-1 pre-dose and H2, H4 and H9 post-dose
Urinary aldosterone
Time frame: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Urinary cortisol
Time frame: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
Urinary creatinin
Time frame: H-12 to H0 pre-dose, H0-H6, H6-H12 and H12-H24 post-dose
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 16 Jul 2013.
- Derived from this study: PubMed 33027067Khosla J, Aronow WS, Frishman WH. Firibastat: An Oral First-in-Class Brain Aminopeptidase A Inhibitor for Systemic Hypertension. Cardiol Rev. 2022 Jan-Feb 01;30(1):50-55. doi: 10.1097/CRD.0000000000000360.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 QGC001 [(3S,3'S)-4,4'-dithiobis (3-aminobutane-1-sulfonic acid)] in people with Essential Hypertension, run by Quantum Genomics SA at 1 site in France.
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 6 inclusion and 11 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 16 Jul 2013. 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 France. 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 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?
Adverse events (time frame: up to 11 days). The study lists 32 primary outcomes in all. 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 NCT01900171, which also lists 1 linked publication.
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 16 Jul 2013.