Skip to main content
OpenTrials
Completed

NCT Number: NCT01785472

Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Asian Patients With Essential Hypertension

This study will assess the efficacy and safety of multiple doses of LCZ696 compared to olmesartan in Asian patients with essential hypertension

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy.
  • Treated patients (using antihypertensive treatments within 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at the randomization visit (Visit 201) and msSBP≥140 mmHg <180 mmHg at the visit immediately preceding Visit 201 (Visit 102 or 103).
  • Untreated patients (newly diagnosed with essential hypertension or having a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to Visit 1) must have an msSBP≥150 mmHg and <180 mmHg at both Visit 1 and Visit 201.
  • Patients must have an absolute difference of ≤15 mmHg in msSBP between Visit 201 and the immediately preceding visit.

Exclusion criteria

  • Patients with severe hypertension (msDBP ≥110 mmHg and or msSBP ≥180 mmHg).
  • History of angioedema, drug-related or otherwise, as reported by the patient.
  • History or evidence of a secondary form of hypertension, including but not limited to any of the following: renal parenchymal hypertension, renovascular hypertension (unilateral or bilateral renal artery stenosis), coarctation of the aorta, primary hyperaldosteronism, Cushing's disease, pheochromocytoma, polycystic kidney disease, and drug-induced hypertension.
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled into the active drug treatment epoch.

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

LCZ696

Drug

LCZ696 200 mg tablet

Olmesartan

Drug

Olmesartan 20 mg capsule

Placebo of LCZ696

Drug

Placebo tablet of LCZ696 200 mg once daily

Placebo of Olmesartan

Drug

Placebo capsule of olmesartan 20 mg once daily

Primary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 200 mg Versus Olmesartan 20 mg

    Time frame: baseline, 8 weeks

    Sitting 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.

Secondary outcomes

  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) Between LCZ696 400 mg Versus Olmesartan 20 mg

    Time frame: baseline, 8 weeks

    Sitting 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

  2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) Between LCZ696 200, and LCZ696 400 mg Versus Olmesartan 20 mg

    Time frame: baseline, 8 weeks

    Sitting BP measurements were performed at screening through the end of the study at every study visit. A negative change from baseline indicates improvement

  3. Change From Baseline in Office Pulse Pressure (msPP)

    Time frame: baseline, 8 weeks

    Four separate sitting BP measurements should be obtained with a full two minute interval between measurements.

  4. Change From Baseline in Mean 24-hour Ambulatory Blood Pressure

    Time frame: baseline, 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.

  5. Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Dippers.

    Time frame: 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

  6. Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Dippers.

    Time frame: 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

  7. Sub-group Analysis for Change From Baseline in Mean Ambulatory Systolic Blood Pressure in Non-dippers.

    Time frame: 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

  8. Sub-group Analysis for Change From Baseline in Mean Ambulatory Diastolic Blood Pressure in Non-dippers.

    Time frame: 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

  9. Number of Patients Achieving Successful Blood Pressure Control

    Time frame: 8 weeks

    Successful blood pressure control is defined as msSBP <140 mmHg and msDBP <90 mmHg.

  10. Change From Baseline in Ambulatory Pulse Pressure

    Time frame: baseline, 8 weeks

    Ambulatory pulse pressure (PP) is calculated by hourly ambulatory SBP and hourly ambulatory DBP over a 24-hour period.

  11. Number of Responders

    Time frame: baseline, 8 weeks

    Responders are patients with msSBP response (<140 mmHg or ≥20 mmHg reduction from baseline) and msDBP response (<90 mmHg or ≥10 mmHg reduction from baseline)

  12. Number of Patients With Adverse Events, Serious Adverse Events, and Death as Assessment of Safety and Tolerability

    Time frame: baseline, 8 weeks

    Participants were monitored for adverse events, serious adverse events and deaths throughout the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Multi-center, Randomized, Double-blind, Active-controlled, 8-week Study to Evaluate the Efficacy and Safety of LCZ696 in Comparison to Olmesartan in Patients With Essential Hypertension

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 7, 2013
Registry last updated
Dec 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.