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Trial · NCT01785472

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mgbaseline, 8 weeksSitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements.
SecondaryChange From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mgbaseline, 8 weeksSitting BP measurements will be performed at screening through end of study at every visit. Four separate sitting BP measurements will be obtained with a full two minute interval between measurements
SecondaryChange From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mgbaseline, 8 weeksSitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement
SecondaryChange From Baseline in Office Pulse Pressure (msPP)baseline, 8 weeksFour separate sitting BP measurements should be obtained with a full two minute interval between measurements.
SecondaryChange From Baseline in Mean 24-hour Ambulatory Blood Pressurebaseline, 8 weeks
In this analysis, mean 24 hour ambulatory systolic blood pressure maSBP, mean 24 hour ambulatory diastolic blood pressure maDBP, daytime and nightime maSBP and maDBP will be reported. Ambulatory blood pressure monitoring over a 24 hour period will be conducted at two time points during the study.
SecondarySub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.baseline, 8 weeks
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
SecondarySub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.baseline, 8 weeks
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
SecondarySub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.baseline, 8 weeks
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
SecondarySub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.baseline, 8 weeks
Twenty four hour ABPM was performed twice duirng the study at baseline and week 8. The second ABPM assessment was performed only in participants who had successfully completed the ABPM assessment at baseline. Dippers were defined as participants who showed a decrease of at least 10% in maSBP during the night (10pm-6am) compared with the daytime level. A negative change from baseline indicates improvement
SecondaryNumber of Patients Achieving Successful Blood Pressure Control8 weeksSuccessful blood pressure control is defined as msSBP \<140 mmHg and msDBP \<90 mmHg.
SecondaryChange From Baseline in Ambulatory Pulse Pressurebaseline, 8 weeksAmbulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.
SecondaryNumber of Respondersbaseline, 8 weeksResponders are patients with msSBP response (\<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (\<90 mmHg or ≥10 mmHg reduction from baseline)
SecondaryNumber of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerabilitybaseline, 8 weeksParticipants were monitored for adverse events, serious adverse events and deaths throughout the study.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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