Trial · NCT00549770
Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
NCT00549770, Phase 2, Completed, Novartis Pharmaceuticals; results first posted 2015-08-10
3 sourcestrials-2026-11-12-0.5.0
Download JSON
Cite this record
ConductScience Library. Efficacy and Safety of LCZ696A in Patients With Essential Hypertension. Trials, record NCT00549770. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00549770
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of LCZ696A in Patients With Essential Hypertension
- NCT number
- NCT00549770
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 1,334 participants, actual
- Lead sponsor
- Novartis Pharmaceuticals
- Conditions
- Hypertension
- Interventions
- LCZ696, Valsartan, AHU377, Placebo
- First posted
- 2007-10-26
- Last updated
- 2015-08-25
- Results first posted
- 2015-08-10
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | baseline, week 8 | Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement. |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | baseline, week 8 | Sitting BP measurements were performed at screening through the end of the study at every study visit. |
| Secondary | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | baseline, 8 weeks | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. |
| Secondary | Change From Baseline in Daytime maDBP and maSBP | baseline, 8 weeks | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the avergae of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Daytime mean SBP and DBP were the averages of the hourly means between 6 am and 10 pm. |
| Secondary | Change From Baseline in Nighttime maDBP and maSBP | baseline, 8 weeks | Hourly mean ambulatory DBP and SBP post-dosing was calculated for each post-dosing hour over 24 hours by taking the average of the readings taken in the corresponding post-dosing hour at randomization and at week 8. Nighttime mean SBP and DBP were the averages of the hourly means between 10 pm and 6 am. |
| Secondary | Percentage of Participants Who Achieved a Successful Response in msDBP | 8 weeks | Successful response in msDBP is defined as msDBP \<90 mmHg or a reduction ≥ 10 mmHg from baseline. |
| Secondary | Percentage of Participants Who Achieved a Successful Response in msSBP | 8 weeks | Successful response in msSBP is defined as msSBP \<140 mmHg or a reduction ≥ 20 mmHg from baseline. |
| Secondary | Percentage of Participants Who Achieved Successful Control in msDBP | 8 weeks | Successful control in msDBP is defined as msDBP \<90 mmHg. |
| Secondary | Percentage of Participants Who Achieved Successful Control in msSBP | 8 weeks | Successful control in msSBP is defined as \<140 mmHg. |
Source ClinicalTrials.gov
Outcomes9
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 Mean Sitting Diastolic Blood Pressure (msDBP) | baseline, week 8 | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | baseline, week 8 | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in 24-hour Mean Ambulatory DBP (maDBP) and maSBP | baseline, 8 weeks | Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Daytime maDBP and maSBP | baseline, 8 weeks | Ambulatory Blood Pressure Monitoring (ABPM) Subset: The ABPM subest included all ITT participants who had both baseline and week 8 ABPM values. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Nighttime maDBP and maSBP | baseline, 8 weeks | Participants from the ABPM subset, who had both baseline nighttime and week 8 nighttime values, were included in the analysis only. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants Who Achieved a Successful Response in msDBP | 8 weeks | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved a Successful Response in msSBP | 8 weeks | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Successful Control in msDBP | 8 weeks | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Achieved Successful Control in msSBP | 8 weeks | Intent-to-treat (ITT): The ITT included all randomized participants who had a baseline and at least one post-baseline efficacy measuremet during the 8-week core treatment period. | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group96
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 Mean Sitting Diastolic Blood Pressure (msDBP) | LCZ696 100 mg | -9.97 | Standard Error 0.73 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | LCZ696 200 mg | -12.92 | Standard Error 0.70 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | LCZ696 400 mg | -13.63 | Standard Error 0.70 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Valsartan 80 mg | -9.14 | Standard Error 0.72 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Valsartan 160 mg | -9.95 | Standard Error 0.71 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Valsartan 320 mg | -10.93 | Standard Error 0.71 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | AHU377 200 mg | -9.76 | Standard Error 0.71 | mmHg | |
| Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) | Placebo | -6.78 | Standard Error 0.69 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | LCZ696 100 mg | -13.75 | Standard Error 1.15 | mmHg | |
| Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) | LCZ696 200 mg | -18.70 | Standard Error 1.10 | mmHg |
1 to 10 of 96Source ClinicalTrials.gov
See all 96 results by groupParticipant flow40
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | LCZ696 100 mg | 156 | |
| Overall Study | STARTED | LCZ696 200 mg | 169 | |
| Overall Study | STARTED | LCZ696 400 mg | 172 | |
| Overall Study | STARTED | Valsartan 80 mg | 163 | |
| Overall Study | STARTED | Valsartan 160 mg | 166 | |
| Overall Study | STARTED | Valsartan 320 mg | 164 | |
| Overall Study | STARTED | AHU377 200 mg | 165 | |
| Overall Study | STARTED | Placebo | 173 | |
| Overall Study | Intent-to-treat Population | LCZ696 100 mg | 154 | |
| Overall Study | Intent-to-treat Population | LCZ696 200 mg | 168 |
1 to 10 of 40Source ClinicalTrials.gov
See all 40 participant flowAdverse events48
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 | Headache | Nervous system disorders | LCZ696 100 mg | 4 | 156 | |
| other | Headache | Nervous system disorders | LCZ696 200 mg | 4 | 169 | |
| other | Headache | Nervous system disorders | LCZ696 400 mg | 4 | 172 | |
| other | Headache | Nervous system disorders | Valsartan 80 mg | 5 | 163 | |
| other | Headache | Nervous system disorders | Valsartan 160 mg | 4 | 166 | |
| other | Headache | Nervous system disorders | Valsartan 320 mg | 3 | 164 | |
| other | Headache | Nervous system disorders | AHU377 200 mg | 5 | 165 | |
| other | Headache | Nervous system disorders | Placebo | 13 | 173 | |
| serious | Road traffic accident | Injury, poisoning and procedural complications | LCZ696 100 mg | 1 | 156 | |
| serious | Road traffic accident | Injury, poisoning and procedural complications | LCZ696 200 mg | 0 | 169 |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 adverse eventsAdverse event totals24
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | LCZ696 100 mg | ||
| Total, all-cause mortality | LCZ696 200 mg | ||
| Total, all-cause mortality | LCZ696 400 mg | ||
| Total, all-cause mortality | Valsartan 80 mg | ||
| Total, all-cause mortality | Valsartan 160 mg | ||
| Total, all-cause mortality | Valsartan 320 mg | ||
| Total, all-cause mortality | AHU377 200 mg | ||
| Total, all-cause mortality | Placebo | ||
| Total, other adverse events | LCZ696 100 mg | 4 | 156 |
| Total, other adverse events | LCZ696 200 mg | 4 | 169 |
1 to 10 of 24Source ClinicalTrials.gov
See all 24 adverse event totalsPapers2
The papers the trial lists on ClinicalTrials.gov.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT00549770
GET https://conductscience.org/api/trials/v1/NCT00549770/results?page=2