Trial · NCT00817635
A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
NCT00817635, Phase 2, Completed, Novartis; results first posted 2021-06-02
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension. Trials, record NCT00817635. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00817635
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of LCI699 Compared to Placebo in Participants With Resistant Hypertension
- NCT number
- NCT00817635
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 155 participants, actual
- Lead sponsor
- Novartis
- Conditions
- Hypertension
- Interventions
- LCI699, Eplerenone, LCI699-matching Placebo, Eplerenone-matching Placebo
- First posted
- 2009-01-06
- Last updated
- 2021-06-02
- Other registries' IDs
- eudract:2008-007338-23
- Results first posted
- 2021-06-02
Source ClinicalTrials.gov
Registered outcomes16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) | Baseline, Week 8 | Arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and country as factors and Baseline MSSBP as a covariate. |
| Secondary | Change From Baseline in MSDBP at Week 8 LOCF | Baseline, Week 8 | Arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSDBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate. |
| Secondary | Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8, as Measured by Office Blood Pressure (OBP) | Week 8 | MSSBP response was defined as the percentage of participants with a MSSBP \<140 mmHg or a \>=20 mmHg reduction from baseline reduction from baseline. MSSBP control was defined as the percentage of participants with a MSSBP \<140 mmHg for non-diabetic participants and \<130mHg for diabetic participants. |
| Secondary | Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8, as Measured by OBP | Week 8 | MSDBP response was defined as the percentage of participants with a MSDBP \<90 mmHg or a \>=10 mmHg reduction from baseline. MSDBP control was defined as the percentage of participants with a MSDBP \<90 mmHg for non-diabetic participants and \<80mHg for diabetic participants. |
| Secondary | Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSSBP at Week 8 | Baseline, Week 8 | Arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSSBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSSBP as a covariate. |
| Secondary | Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSDBP at Week 8 | Baseline, Week 8 | Arterial BP determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from Baseline in MSDBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate. |
| Secondary | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) at Week 8 LOCF, as Measured by Ambulatory Blood Pressure Measurement (ABPM) | Baseline, Week 8 | An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings, using an automated validated monitoring device from Baseline to Week 8. The 24-hour SBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24-hour period. The change from Baseline in SBP was analyzed using ANCOVA with treatment and country as factors and Baseline MSSBP as a covariate. |
| Secondary | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) at Week 8 LOCF, as Measured by ABPM | Baseline, Week 8 | An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings, using an automated validated monitoring device from Baseline to Week 8. The 24-hour DBP was calculated by taking the mean of all ambulatory diastolic blood pressure readings for the 24-hour period. The change from Baseline in DBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate. |
| Secondary | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime SBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM | Baseline, Week 4 | An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings using an automated validated monitoring device from Baseline to Week 4. The 24-hour SBP was calculated by taking the mean of all ambulatory systolic blood pressure readings for the 24-hour period. The change from Baseline in SBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate. |
| Secondary | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime DBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM | Baseline, Week 4 | An ABPM measured a participant's blood pressure over a 24-hour period including daytime and nighttime readings using an automated validated monitoring device from Baseline to Week 4. The 24-hour DBP was calculated by taking the mean of all ambulatory diastolic blood pressure readings for the 24-hour period. The change from Baseline in DBP was analyzed using an ANCOVA with treatment and country as factors and Baseline MSDBP as a covariate. |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 registered outcomesOutcomes16
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) | Baseline, Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | mmHg | MEAN |
| SECONDARY | Change From Baseline in MSDBP at Week 8 LOCF | Baseline, Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | mmHg | MEAN |
| SECONDARY | Percentage of Participants With a MSSBP Response and MSSBP Control at Week 8, as Measured by Office Blood Pressure (OBP) | Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With a MSDBP Response and MSDBP Control at Week 8, as Measured by OBP | Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | percentage of participants | NUMBER |
| SECONDARY | Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSSBP at Week 8 | Baseline, Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | mmHg | MEAN |
| SECONDARY | Dose/Exposure BP Response Relationship of LCI699, as Measured by Change From Baseline in MSDBP at Week 8 | Baseline, Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Systolic Blood Pressure (SBP) at Week 8 LOCF, as Measured by Ambulatory Blood Pressure Measurement (ABPM) | Baseline, Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime Diastolic Blood Pressure (DBP) at Week 8 LOCF, as Measured by ABPM | Baseline, Week 8 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime SBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM | Baseline, Week 4 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. Here, Number Analyzed 'n' represents number of participants who were evaluable for that specific category. | mmHg | MEAN |
| SECONDARY | Change From Baseline in Mean 24 Hours, Mean Daytime and Mean Nighttime DBP in LCI699 1mg QD Versus LCI699 0.5mg BID Arm at Week 4, as Measured by ABPM | Baseline, Week 4 | FAS population included all participants who were randomized and received at least 1 dose of study drug. Overall number of participants analyzed signifies the number of participants who were evaluable for this measure. Here, Number Analyzed 'n' represents number of participants who were evaluable for that specific category. | mmHg | MEAN |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 outcomesResults by group129
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) | LCI699 0.25 mg BID | -11.4 | Standard Error 2.96 | mmHg | |
| Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) | LCI699 1 mg QD | -13.1 | Standard Error 3.24 | mmHg | |
| Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) | LCI699 0.5 mg Followed by LCI699 1 mg BID | -12.5 | Standard Error 2.96 | mmHg | |
| Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) | Eplerenone 50 mg BID | -18.7 | Standard Error 2.92 | mmHg | |
| Change From Baseline in MSSBP at Week 8 Last Observation Carried Forward (LOCF) | Placebo | -8.8 | Standard Error 2.87 | mmHg | |
| Change From Baseline in MSDBP at Week 8 LOCF | LCI699 0.25 mg BID | -4.5 | Standard Error 1.72 | mmHg | |
| Change From Baseline in MSDBP at Week 8 LOCF | LCI699 1 mg QD | -6.0 | Standard Error 1.88 | mmHg | |
| Change From Baseline in MSDBP at Week 8 LOCF | LCI699 0.5 mg Followed by LCI699 1 mg BID | -6.1 | Standard Error 1.72 | mmHg | |
| Change From Baseline in MSDBP at Week 8 LOCF | Eplerenone 50 mg BID | -7.7 | Standard Error 1.69 | mmHg | |
| Change From Baseline in MSDBP at Week 8 LOCF | Placebo | -4.8 | Standard Error 1.66 | mmHg |
1 to 10 of 129Source ClinicalTrials.gov
See all 129 results by groupParticipant flow15
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCI699 0.25 mg BID | 32 | |
| Overall Study | STARTED | LCI699 1 mg QD | 26 | |
| Overall Study | STARTED | LCI699 0.5 mg Followed by LCI699 1 mg BID | 31 | |
| Overall Study | STARTED | Eplerenone 50 mg BID | 33 | |
| Overall Study | STARTED | Placebo | 33 | |
| Overall Study | COMPLETED | LCI699 0.25 mg BID | 23 | |
| Overall Study | COMPLETED | LCI699 1 mg QD | 22 | |
| Overall Study | COMPLETED | LCI699 0.5 mg Followed by LCI699 1 mg BID | 28 | |
| Overall Study | COMPLETED | Eplerenone 50 mg BID | 28 | |
| Overall Study | COMPLETED | Placebo | 25 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 participant flowAdverse events450
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Palpitations | Cardiac disorders | LCI699 0.25 mg BID | 0 | 32 | |
| other | Palpitations | Cardiac disorders | LCI699 1.0 mg QD | 0 | 26 | |
| other | Palpitations | Cardiac disorders | LCI699 0.5 mg Followed by LCI699 1 mg BID | 0 | 31 | |
| other | Palpitations | Cardiac disorders | Eplerenone 50 mg BID | 1 | 33 | |
| other | Palpitations | Cardiac disorders | Placebo | 0 | 33 | |
| other | Inner ear inflammation | Ear and labyrinth disorders | LCI699 0.25 mg BID | 0 | 32 | |
| other | Inner ear inflammation | Ear and labyrinth disorders | LCI699 1.0 mg QD | 0 | 26 | |
| other | Inner ear inflammation | Ear and labyrinth disorders | LCI699 0.5 mg Followed by LCI699 1 mg BID | 0 | 31 | |
| other | Inner ear inflammation | Ear and labyrinth disorders | Eplerenone 50 mg BID | 0 | 33 | |
| other | Inner ear inflammation | Ear and labyrinth disorders | Placebo | 1 | 33 |
1 to 10 of 450Source ClinicalTrials.gov
See all 450 adverse eventsAdverse event totals15
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCI699 0.25 mg BID | 0 | 32 |
| Total, all-cause mortality | LCI699 1.0 mg QD | 0 | 26 |
| Total, all-cause mortality | LCI699 0.5 mg Followed by LCI699 1 mg BID | 0 | 31 |
| Total, all-cause mortality | Eplerenone 50 mg BID | 0 | 33 |
| Total, all-cause mortality | Placebo | 0 | 33 |
| Total, other adverse events | LCI699 0.25 mg BID | 15 | 32 |
| Total, other adverse events | LCI699 1.0 mg QD | 15 | 26 |
| Total, other adverse events | LCI699 0.5 mg Followed by LCI699 1 mg BID | 8 | 31 |
| Total, other adverse events | Eplerenone 50 mg BID | 13 | 33 |
| Total, other adverse events | Placebo | 16 | 33 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24107737 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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