HypertensionPhase 2NCT01373086
LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension
A Phase 2 study testing LFF269 and Eplerenone in people with Hypertension, run by Novartis Pharmaceuticals at 11 sites in United States.
Trial summary
This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- LFF269 and Eplerenone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 11 sitesUnited States
- Study dates
- May 2011to Oct 2011
- Phase
- Phase 2
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female (post-menopausal or surgically sterile).
- Age from 18 to 75 years inclusive.
- Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
Who cannot join
- History or evidence of a secondary form of hypertension,
- History of cardiovascular disease. Type 1 or type 2 diabetes mellitus.
- Clinically significant valvular heart disease.
- Other protocol-defined inclusion/exclusion criteria may apply
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Advanced Clinical Research Institute-Phase I
Anaheim, California, 92801
Comprehensive Phase I
Fort Myers, Florida, 333901
Clinical Research Advantage/ Prairie Fields Family Medicine, PC
Fremont, Nebraska, 68025
Clinical Research Advantage/ Aloha Medical
Las Vegas, Nevada, 89183
Comprehensive Phase One®,
Miramar, Florida, 33025
Internal Medicine Physicians
Omaha, Nebraska, 68130
ICON Developmental Solutions
Omaha, Nebraska, 68154
ICON Development Solutions,
San Antonio, Texas, 78209
Comprehensive NeuroScience
St. Petersburg, Florida, 33716
Clinical Research Atlanta
Stockbridge, Georgia, 30281
Comprehensive Clinical Development NW, Inc.
Tacoma, Washington, 98418
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Proof-of-concept Study to Evaluate the Efficacy and Safety of LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension
This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.
- Conditions
- Hypertension
- Being tested
- LFF269, Eplerenone, Placebo
- Keywords
- Hypertension,, mild hypertension,, moderate hypertension,, high blood pressure,, uncomplicated hypertension.
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LFF269Drug
EplerenoneDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| LFF269 low dose | Experimental | LFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period Receives: Drug: LFF269; Drug: Placebo |
| LFF269 high dose | Experimental | LFF269 high dose + Matching Placebo to Eplerenone 50mg Receives: Drug: LFF269; Drug: Placebo |
| Eplerenone | Active comparator | Eplerenone 50mg twice daily + matching placebo of LFF269 Receives: Drug: Eplerenone; Drug: Placebo |
| Placebo | Placebo comparator | Placebo of LFF269 high dose + Placebo of Eplerenone 50 mg Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment
Measured: Baseline, week 4
Secondary outcomes (7)
Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment
Measured: Baseline, week 4
Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment
Measured: Baseline, week 4
Percentage of patients experiencing adverse events during the study as measure of safety and tolerability
Adverse events will be reported as percentage of patients with total adverse events, serious adverse events and death.
Measured: 4 weeks
Change from baseline in mean sitting SBP and DBP after 4 weeks treatment
Measured: Baseline, week 4
Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)
Measured: 4 weeks
change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment
Measured: Baseline, week 4
Pharmacokinetics of LFF269: Plasma concentrations of LFF269
Measured: pre dose & 6 hours post study drug dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2011 (estimated)
- Study startMay 2011
- Primary completionOct 2011
- Study completionOct 2011
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 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 19 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
- NCT01373086
- Sponsor's protocol ID
- CLFF269X2201
- Status last verified
- Nov 2012
- First submitted
- 24 May 2011
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo and Active Controlled, Parallel Group, Proof-of-concept Study to Evaluate the Efficacy and Safety of LFF269 Compared to Placebo After Treatment in Subjects With Essential Hypertension
- ClinicalTrials.gov ID
- NCT01373086
- Acronym / sponsor ID
- CLFF269X2201
- Conditions
- Hypertension
- Keywords
- Hypertension,, mild hypertension,, moderate hypertension,, high blood pressure,, uncomplicated hypertension.
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Novartis PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- May 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 14 Jun 2011 (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.
This study will assess the efficacy and safety of LFF269 compared to placebo after treatment in subjects with essential hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| LFF269 low dose | Experimental | Drug: LFF269, Drug: PlaceboLFF269 low dose + Matching Placebo to Eplerenone 50mg during 4 week double blind period |
| LFF269 high dose | Experimental | Drug: LFF269, Drug: PlaceboLFF269 high dose + Matching Placebo to Eplerenone 50mg |
| Eplerenone | Active comparator | Drug: Eplerenone, Drug: PlaceboEplerenone 50mg twice daily + matching placebo of LFF269 |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of LFF269 high dose + Placebo of Eplerenone 50 mg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male and female (post-menopausal or surgically sterile).
- Age from 18 to 75 years inclusive.
- Subjects with mild-to-moderate uncomplicated essential hypertension, with (not more than 2 in combination) or without prior treatment.
- Subjects must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 36 kg/m2.
Key exclusion criteria (4 listed)
- History or evidence of a secondary form of hypertension,
- History of cardiovascular disease. Type 1 or type 2 diabetes mellitus.
- Clinically significant valvular heart disease.
- Other protocol-defined inclusion/exclusion criteria may apply
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 |
|---|---|---|
| LFF269 | Drug | LFF269 high dose, LFF269 low dose |
| Eplerenone | Drug | Eplerenone |
| Placebo | Drug | Eplerenone, LFF269 high dose, LFF269 low dose, Placebo |
Primary outcome
Change from baseline in mean 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment
Time frame: Baseline, week 4
7 secondary outcomes
Change from baseline in mean 24-hour diastolic blood pressure (DBP) as measured by ABPM after 4 weeks of treatment
Time frame: Baseline, week 4
Change from baseline in mean 24-hour SBP and DBP as measured by ABPM after 4 weeks treatment
Time frame: Baseline, week 4
Percentage of patients experiencing adverse events during the study as measure of safety and tolerability
Time frame: 4 weeks
Change from baseline in mean sitting SBP and DBP after 4 weeks treatment
Time frame: Baseline, week 4
Percentage of patients achieving a successful BP response (> placebo) and BP control (SBP < 140 mmHg at trough)
Time frame: 4 weeks
change from baseline in mean daytime and mean nighttime SBP and DBP as measured by ABPM after 4 weeks treatment
Time frame: Baseline, week 4
Pharmacokinetics of LFF269: Plasma concentrations of LFF269
Time frame: pre dose & 6 hours post study drug dose
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Results for CLFF269X2201 from the Novartis Clinical Trials websiteLink provided by the sponsor.
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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
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing LFF269 and Eplerenone in people with Hypertension, run by Novartis Pharmaceuticals at 11 sites in United States.
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 4 inclusion and 4 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: stopped early, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early. Results are not available in the source record.
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 24-hour systolic blood pressure (SBP) as measured by ambulatory blood pressure monitoring (ABPM) after 4 weeks treatment (time frame: Baseline, week 4). 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 17 Dec 2020.