HypertensionPhase 3NCT01150357
Safety and Efficacy of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
A Phase 3 study testing Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg) and Aliskiren (150/300/600 mg) in people with Hypertension, run by Novartis Pharmaceuticals at 48 sites in 9 countries.
Trial summary
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg) and Aliskiren (150/300/600 mg)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 267 participants
- Where
- 48 sitesin 9 countries
- Study dates
- Jun 2010to Aug 2014
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
- msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004
Who cannot join
- Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
- Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
- msSBP ≥ 25% above the 95th percentile
- Second or third degree heart block without a pacemaker
- AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
- Total bilirubin > 2 times the upper limit of the reference range
Show all 9Show fewer
- Creatinine clearance < 30 mL/min/1.73m² (calculated using Modified Schwartz formula to estimate glomerular filtration rate [GFR]), based on the serum creatinine concentration obtained at the screening visit)
- WBC count < 3000/mm³
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
48 sites in 9 countries.
48 sites in 9 countries
United States23 sites
Novartis Investigative Site
Amarillo, Texas, 79106
Novartis Investigative Site
Atlanta, Georgia, 30322
Novartis Investigative Site
Birmingham, Alabama, 35294-0006
Novartis Investigative Site
Charleston, South Carolina, 29425
Novartis Investigative Site
Charleston, West Virginia, 25304
Novartis Investigative Site
Columbus, Ohio, 43205
Novartis Investigative Site
Dalton, Georgia, 30721
Novartis Investigative Site
Hackensack, New Jersey, 07601
Novartis Investigative Site
Hattiesburg, Mississippi, 39401
Novartis Investigative Site
Jackson, Mississippi, 39209
Novartis Investigative Site
Lewiston, Idaho, 83501
Novartis Investigative Site
Little Rock, Arkansas, 72202
Novartis Investigative Site
Los Angeles, California, 90048
Novartis Investigative Site
Louisville, Kentucky, 40202
Novartis Investigative Site
New York, New York, 10016
Novartis Investigative Site
Park Ridge, Illinois, 60068
Novartis Investigative Site
Pensacola, Florida, 32504
Novartis Investigative Site
Pittsburgh, Pennsylvania, 15224
Novartis Investigative Site
Portland, Oregon, 97225
Novartis Investigative Site
Portland, Oregon, 97239
Novartis Investigative Site
San Diego, California, 92123
Novartis Investigative Site
Seattle, Washington, 98105
Novartis Investigative Site
Toledo, Ohio, 43606
Hungary7 sites
Novartis Investigative Site
Budapest, 1083
Novartis Investigative Site
Budapest, 1131
Novartis Investigative Site
Debrecen, 4032
Novartis Investigative Site
Miskolc, 3529
Novartis Investigative Site
Nyíregyháza, Hungary, 4400
Novartis Investigative Site
Szeged, Hungary, 6725
Novartis Investigative Site
Veszprém, H-8200
Slovakia6 sites
Novartis Investigative Site
Bratislava, Slovakia, 84103
Novartis Investigative Site
Bratislava, Slovakia, 85107
Novartis Investigative Site
Martin, Slovakia, 03601
Novartis Investigative Site
Myjava, Slovakia, 90701
Novartis Investigative Site
Prešov, Slovakia, 08001
Novartis Investigative Site
Trnava, Slovakia, 91701
Belgium4 sites
Novartis Investigative Site
Brussels, 1090
Novartis Investigative Site
Edegem, 2650
Novartis Investigative Site
Ghent, 9000
Novartis Investigative Site
Leuven, 3000
Turkey (Türkiye)4 sites
Novartis Investigative Site
Ankara, Turkey, 06100
Novartis Investigative Site
Ankara, Turkey, 06490
Novartis Investigative Site
Ankara, Turkey, 06500
Novartis Investigative Site
Izmir, 35340
Guatemala1 site
Novartis Investigative Site
Guatemala City, Departamento de Guatemala, 01010
About this study
Official title: A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
- Conditions
- Hypertension
- Being tested
- Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg), Aliskiren (150/300/600 mg)
- Keywords
- Pediatric hypertension, primary hypertension, secondary hypertension
- Medical subject headings
- Hypertension, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aliskiren (6.25/12.5/25 mg)Drug
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren.
Aliskiren (37.5/75/150 mg)Drug
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
Aliskiren (150/300/600 mg)Drug
Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Aliskiren | Experimental | Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren. Receives: Drug: Aliskiren (6.25/12.5/25 mg) |
| Mid dose | Experimental | Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren. Receives: Drug: Aliskiren (37.5/75/150 mg) |
| High dose | Experimental | Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren. Receives: Drug: Aliskiren (150/300/600 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Measured: Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Measured: Week 4 to endpoint (Week 8 or LOCF)
Secondary outcomes (11)
Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)
Adverse events (AEs) were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. Serious adverse events (SAEs) were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Measured: Baseline up to Week 4
Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)
AEs were defined as any unfavorable and unintended diagnosis, symptom, sign (including an abnormal laboratory finding), syndrome or disease which either occurs during study, having been absent at baseline, or, if present at baseline, appears to worsen. SAEs were defined as any untoward medical occurrences that result in death, are life threatening, require (or prolong) hospitalization, cause persistent or significant disability/incapacity, result in congenital anomalies or birth defects, or are other conditions which in judgement of investigators represent significant hazards.
Measured: From Week 4 to Week 8
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Measured: Baseline to endpoint (Week 4 or LOCF)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sDBP measurements were used as the average sitting office blood pressure for that visit.
Measured: Week 4 to endpoint (Week 8 or LOCF)
Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)
MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of diastolic blood pressure (DBP) and one third of difference between systolic blood pressure (SBP) and DBP i.e. MAP = DBP+1/3*(SBP-DBP).
Measured: Baseline to endpoint (Week 4 or LOCF)
Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)
MAP was defined as the average arterial pressure during a single cardiac cycle. The MAP was measured as sum of DBP and one third of difference between SBP and DBP i.e. MAP = DBP+1/3*(SBP-DBP).
Measured: Week 4 to endpoint (Week 8 or LOCF)
Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)
Treatment responders were defined as participants with msSBP less than 95th percentile (for age, gender and height) or a 7 mmHg decrease in msSBP from the baseline.
Measured: Baseline to endpoint (Week 4 or LOCF)
Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)
Ambulatory Blood Pressure Monitoring (ABPM) was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. The participants who were selected for this evaluation wore the ABPM device for 24 hours, returned to the clinic upon completion of the 24-hour monitoring period for removal of device and BP assessments. The ABPM device was pre-set to collect readings every 20 minutes. Mean hourly systolic and diastolic blood pressure were calculated for each participant at post dosing 1 - 24 hours.
Measured: Baseline to endpoint (Week 4 or LOCF)
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)
ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Day time was defined as the average of the hourly means between 6 am and 10 pm while the night time mean was the average of the hourly means between 10 pm and 6 am.
Measured: Baseline to Week 4
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)
ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Dippers were defined as those participants in whom there was a decrease in mean night time (6pm - 6am) ABPM more than or equal to (≥ ) 10% as compared to average daytime (6am -6pm) ABPM.
Measured: Baseline to endpoint (Week 4 or LOCF)
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)
ABPM was performed over a 24-hour period using an automatic ABPM device to record the blood pressure as per study defined criteria. Non-dippers were defined as those participants in whom there was a decrease in mean night time ABPM less than 10% as compared to average daytime ABPM.
Measured: Baseline to endpoint (Week 4 or LOCF)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionAug 2014
- Study completionAug 2014
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.
- More trials run by Novartis PharmaceuticalsThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 267 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01150357
- Sponsor's protocol ID
- CSPP100A2365
- Other IDs
- 2009-017028-22, 2009
- Status last verified
- Sep 2015
- First submitted
- 23 Jun 2010
- Last updated
- 15 Oct 2015
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, 8 Week Study to Evaluate the Dose Response, Efficacy and Safety of Aliskiren in Pediatric Hypertensive Patients 6-17 Years of Age
- ClinicalTrials.gov ID
- NCT01150357
- Acronym / sponsor ID
- CSPP100A2365
- Conditions
- Hypertension
- Keywords
- Pediatric hypertension, primary hypertension, secondary hypertension
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 267 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 24 Jun 2010 (estimated)
- Results
- Posted 15 Oct 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blind 8 week study will evaluate dose response, efficacy (blood pressure lowering effect) and safety of aliskiren in children 6 - 17 years old with hypertension at low, mid and high weight-based doses. The low dose ranges from 6.25 mg to 25 mg of aliskiren, the mid dose ranges from 37.5 mg to 150 mg of aliskiren and the high dose ranges from 150 mg to 600 mg of aliskiren. This study is being conducted to support monotherapy registration of aliskiren for the treatment of hypertension in children 6-17 years of age.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Aliskiren | Experimental | Drug: Aliskiren (6.25/12.5/25 mg)Participants received body-weight stratified dose of aliskiren capsules (6.25/12.5/25 mg) once daily. Participants whose body weight ≥ 20 kilogram (kg) to less than < 50 kg received 6.25 mg; ≥50 kg and < 80 kg received 12.5 mg and ≥ 80 kg and ≤ 150 kg received 25 mg of aliskiren. |
| Mid dose | Experimental | Drug: Aliskiren (37.5/75/150 mg)Participants received body-weight stratified dose of aliskiren capsules (37.5/75/150 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 37.5 mg; ≥50 kg and < 80 kg received 75 mg and ≥ 80 kg and ≤ 150 kg received 150 mg of aliskiren. |
| High dose | Experimental | Drug: Aliskiren (150/300/600 mg)Participants received body-weight stratified dose of aliskiren capsules (150/300/600 mg) once daily. Participants whose body weight ≥ 20 kg to < 50 kg received 150 mg; ≥50 kg and < 80 kg received 300 mg and ≥ 80 kg and ≤ 150 kg received 600 mg of aliskiren. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Documented diagnosis of hypertension as defined in the NHLBI 4th Report, 2004
- msSBP (mean of 3 measurements) must be ≥ 95th percentile for age, gender and height, at Visit 2 (randomization) measurement as defined by the NHLBI 4th Report, 2004
Key exclusion criteria (9 listed)
- Patient receiving immunosuppressant medication (e.g. cyclosporine, MMF, etc) other than oral/topical steroids, for any medical condition
- Current diagnosis of heart failure (NYHA Class II-IV) or history of cardiomyopathy or obstructive valvular disease
- msSBP ≥ 25% above the 95th percentile
- Second or third degree heart block without a pacemaker
- AST/SGOT or ALT/SGPT >3 times the upper limit of the reference range
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 |
|---|---|---|
| Aliskiren (6.25/12.5/25 mg)Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the low dose arm, participants used one or more of the 6.25 mg capsule (containing 2 minitablets) once daily to reach the body-weight stratified dose of aliskiren. | Drug | Low Dose Aliskiren |
| Aliskiren (37.5/75/150 mg)Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the medium dose arm, participants used one or more of the 37.5 mg capsule (containing 12 minitablets) once daily to reach the body- weight stratified dose of aliskiren. | Drug | Mid dose |
| Aliskiren (150/300/600 mg)Aliskiren dispensing capsules containing minitablets (3.125 mg per minitablet). For the high dose arm, participants used one or more of the 150 mg capsule (containing 48 minitablets) once daily to reach the body- weight stratified dose of aliskiren. | Drug | High dose |
Primary outcome
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1)
Time frame: Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
Change in Mean Sitting Systolic Blood Pressure (msSBP) From Week 4 to Endpoint (Phase 2)
Time frame: Week 4 to endpoint (Week 8 or LOCF)
Sitting blood pressure was measured using a calibrated standard sphygmomanometer after the participants remained in sitting position for 5 minutes at clinic during the visit. The repeat sitting measurements were made at 1-2 minute intervals and the mean of three sSBP measurements were used as the average sitting office blood pressure for that visit.
11 secondary outcomes
Number of Participants With Adverse Events and Serious Adverse Events From Baseline to Week 4 (Phase 1)
Time frame: Baseline up to Week 4
Number of Participants With Adverse Events and Serious Adverse Events From Week 4 to Week 8 (Phase 2)
Time frame: From Week 4 to Week 8
Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Endpoint (Phase 1)
Time frame: Baseline to endpoint (Week 4 or LOCF)
Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Week 4 to Endpoint (Phase 2)
Time frame: Week 4 to endpoint (Week 8 or LOCF)
Change From Baseline in Mean Arterial Pressure (MAP) at Endpoint (Phase 1)
Time frame: Baseline to endpoint (Week 4 or LOCF)
Change in Mean Arterial Pressure (MAP) From Week 4 to Endpoint (Phase 2)
Time frame: Week 4 to endpoint (Week 8 or LOCF)
Percentage of Participants Achieving a Positive Treatment Response at Endpoint (Phase 1)
Time frame: Baseline to endpoint (Week 4 or LOCF)
Change From Baseline in Mean Ambulatory Systolic and Diastolic Blood Pressure (MASBP and MADBP) at Endpoint (Phase 1)
Time frame: Baseline to endpoint (Week 4 or LOCF)
Change From Baseline in Mean Ambulatory Systolic Blood Pressure (MASBP) During Day and Night at Week 4 (Phase 1)
Time frame: Baseline to Week 4
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Dipper Participants at Endpoint (Phase 1)
Time frame: Baseline to endpoint (Week 4 or LOCF)
Change From Baseline in Mean Ambulatory Blood Pressure (MABP) in Non--Dipper Participants at Endpoint (Phase 1)
Time frame: Baseline to endpoint (Week 4 or LOCF)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2015.
- 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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
48 sites in 9 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aliskiren (6.25/12.5/25 mg), Aliskiren (37.5/75/150 mg) and Aliskiren (150/300/600 mg) in people with Hypertension, run by Novartis Pharmaceuticals at 48 sites in 9 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 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 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 48 sites in United States, Hungary, Slovakia, Belgium, Turkey (Türkiye) and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 15 Oct 2015). 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?
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Endpoint (Phase 1) (time frame: Baseline to endpoint (Week 4 or Last observation carried forward (LOCF))). 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 15 Oct 2015.