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Completed

NCT Number: NCT01876368

Efficacy and Safety of LCZ696 Compared to Olmesartan in Essential Hypertensive Patients Not Responsive to Olmesartan

This study will assess the efficacy and safety of LCZ696 in comparison to olmesartan in essential hypertensive patients not adequately responsive to olmesartan

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, Buenos Aires, Argentina

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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 drugs within 4 weeks prior to first visit) must have an office msSBP ≥ 145 mmHg and < 180 mmHg after washout epoch and after 4 weeks run-in epoch
  • untreated patients (either newly diagnosed or those patients with a history of hypertension but have not been taking any antihypertensive drugs for at least 4 weeks prior to first visit) must have an offcie msSBP ≥ 150 mmHg and < 180 mmHg at screening and 1 week after screening and must have an office msSBP ≥ 145 mmHg and < 180 mmHg after 4 weeks run-in epoch
  • patients must successfully complete ABPM and pass technical requirements to be qualified for randomization

Exclusion criteria

  • Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg)
  • History of angioedema, drug-related or otherwise
  • 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 (PKD), drug-induced hypertension
  • Patients who previously entered a LCZ696 study and had been randomized or enrolled to receive active drug treatment

Treatment and study plan

LCZ696

Drug

Olmesartan

Drug

Placebo of LCZ696

Drug

Placebo of Olmesartan

Drug

Primary outcomes

  1. Change From Baseline in 24-hour Mean Ambulatory Systolic Blood Pressure (maSBP)

    Time frame: baseline, 8 weeks

    Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The first 24-hour ABPM will be performed beginning at 24 hours prior to baseline visit and the second will be performed 24 hours prior to week 8 visit.

Secondary outcomes

  1. Change From Baseline in Mean 24-hour Ambulatory Diastolic Blood Pressure (maDBP)

    Time frame: baseline, 8 weeks

    Twenty-four hour mean ambulatory blood pressure measurements (ABPM) will be performed at baseline and at end of study (week 8). The 24-hour ABPM measurements are performed beginning 24 hours prior to baseline and week 8 visits.

  2. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)

    Time frame: baseline, 8 weeks

    Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean

  3. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)

    Time frame: baseline, 8 weeks

    Sitting blood pressure (BP) measurement will be taken at every visit from screening through end of study. For each participant at each visit, four separate sitting BP measurements will be obtained (with a full two minute interval between measurements) and averaged to obtain the mean

  4. Change From Baseline in Office Pulse Pressure

    Time frame: baseline, 8 weeks

    Mean sitting pulse pressure (msPP) will be calculated at screening through end of study at every visit. Mean sitting pulse pressure is calculated as msSBP-msDBP.

  5. Number of Patients Achieving Successful Overall Blood Pressure Control

    Time frame: 8 weeks

    Successful overall blood pressure control is defined as both msSBP/msDBP <140/90 mmHg

  6. Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Control

    Time frame: 8 weeks

    Successful mean sitting systolic blood pressure control is defined as msSBP <140 mmHg

  7. Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Control

    Time frame: 8 weeks

    Successful mean sitting diastolic blood pressure control is defined as msDBP <90 mmHg

  8. Number of Patients Achieving Successful Mean Sitting Systolic Blood Pressure (msSBP) Response

    Time frame: baseline, 8 weeks

    Successful mean sitting systolic blood pressure response is defined as msSBP <140 mmHg or a reduction ≥ 20 mmHg from baseline.

  9. Number of Patients Achieving Successful Mean Sitting Diastolic Blood Pressure (msDBP) Response

    Time frame: baseline, 8 weeks

    Successful mean sitting diastolic blood pressure response is defined as msDBP <90 mmHg or a reduction ≥10 mmHg from baseline.

  10. Number of Patients With Total Adverse Events, Serious Adverse Events and Death

    Time frame: 8 weeks

    Number of patients with total adverse events, serious adverse events and death were reported.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized 8-week Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate Efficacy and Safety of LCZ696 200 mg in Comparison With Olmesartan 20 mg in Essential Hypertensive Patients Not Responsive to Olmesartan

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 12, 2013
Registry last updated
Dec 7, 2015

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.

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