Chicago, Illinois 60607

  • Hypertension

Purpose:

To examine the efficacy of LCZ696 in comparison to the ARB olmesartan on Central Aortic Systolic Blood Pressure (CASP) and other measures of central hemodynamics and arterial stiffness in elderly patients with an elevated systolic blood pressure (SBP) and widened pulse pressure (PP).


Criteria:

Inclusion Criteria: 1. Male and female patients ≥ 60 years of age. 2. Patients with essential hypertension, untreated or currently taking antihypertensive therapy. 3. Untreated patients must have an office msSBP ≥150 mmHg and <180 mmHg at Visit 101 and Visit 201 if they are newly diagnosed or have not been treated with antihypertensive drugs for the 4 weeks prior to Visit 1. 4. Treated patients must have an office msSBP ≥140 mmHg and <180 mmHg at Visit 102 (or Visit 103) and msSBP ≥150 mmHg and <180 mmHg at Visit 201 if they have been treated with antihypertensive drugs for the 4 weeks prior to Visit 1. 5. All patients must have pulse pressure >60 mmHg at Visit 201. Pulse pressure is defined as msSBP- msDBP. 6. Patients must have a difference in msSBP within +/-15 mmHg between Visit 201 (randomization) and the visit immediately prior to Visit 201. Exclusion Criteria: 1. Malignant or severe hypertension (grade 3 of WHO classification; msDBP ≥110 mmHg and/or msSBP ≥ 180 mmHg) 2. History of angioedema, drug-related or otherwise. 3. 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. 4. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke. 5. History of myocardial infarction, coronary bypass surgery or any percutaneous coronary intervention (PCI) during the 12 months prior to Visit 1. 6. History of atrial fibrillation or atrial flutter during the 3 months prior to Visit 1, or active atrial fibrillation or atrial flutter on the ECG at screening. Other protocol-defined inclusion/exclusion criteria may apply


Study is Available At:


Original ID:

CLCZ696A2216


NCT ID:

NCT01692301


Secondary ID:

2012-002899-14


Study Acronym:


Brief Title:

Study of the Safety and Efficacy of LCZ696 on Arterial Stiffness in Elderly Patients With Hypertension


Official Title:

A Randomized, Double-blind 52-week Study to Evaluate the Safety and Efficacy of an LCZ696 Regimen Compared to an Olmesartan Regimen on Arterial Stiffness Through Assessment of Central Blood Pressure in Elderly Patients With Hypertension


Overall Status:

Completed


Study Phase:

Phase 2


Genders:

Both


Minimum Age:

60 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Novartis


Oversight Authority:

  • United States: Food and Drug Administration
  • Argentina: Ministry of Health
  • Brazil: Ministry of Health
  • Colombia: National Institutes of Health
  • France: Ministry of Health
  • Germany: Ministry of Health
  • Greece: Ministry of Health and Welfare
  • Italy: Ministry of Health
  • Japan: Ministry of Health, Labor and Welfare
  • Korea: Food and Drug Administration
  • Russia: Pharmacological Committee, Ministry of Health
  • Spain: Ministry of Health
  • Taiwan: Department of Health


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: S


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

454


Enrollment Type:

Actual


Overall Contact Information

Official Name:Novartis Pharmaceuticals
Study Director
Novartis Pharmaceuticals

Study Dates

Start Date:December 2012
Completion Date:April 2015
Completion Type:Actual
Primary Completion Date:April 2015
Primary Completion Type:Actual
Verification Date:October 2015
Last Changed Date:October 5, 2015
First Received Date:September 20, 2012

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Change from baseline in mean 24-hour ambulatory pulse pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean 24-hour diastolic blood pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean 24-hour systolic blood pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean arterial pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean sitting pulse pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean sitting diastolic blood pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean sitting systolic blood pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean central aortic systolic blood pressure at 52 weeks
Time Frame:baseline, 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean aortic pulse wave velocity
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Change from baseline in mean central pulse pressure
Time Frame:baseline, 12 weeks, and 52 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Change from baseline in mean central aortic systolic blood pressure at 12 weeks
Time Frame:baseline, 12 weeks
Safety Issues:False

Study Interventions

Intervention Type:Drug
Name:hydrochlorothiazide
Description:hydrochlorothiazide 6.25mg, 12.5mg, or 25 mg tablets
Arm Name:LCZ696 Regimen
Intervention Type:Drug
Name:amlodipine
Description:amlodipine 2.5 mg or 5 mg tablets
Arm Name:LCZ696 Regimen
Intervention Type:Drug
Name:Olmesartan matching placebo
Description:Olmesartan matching placebo capsule
Arm Name:LCZ696 Regimen
Intervention Type:Drug
Name:LCZ696 matching placebo
Description:LCZ696 Matching Placebo tablet
Arm Name:LCZ696 Regimen
Intervention Type:Drug
Name:Olmesartan
Description:Comparator Drug
Arm Name:Olmesartan Regimen
Intervention Type:Drug
Name:LCZ696
Description:Investigational drug
Arm Name:LCZ696 Regimen

Study Arms

Study Arm Type:Active Comparator
Arm Name:Olmesartan Regimen
Description:Randomized patients will receive olmesartan once daily for four weeks, then will be force-titrated to a higher dose at Week 4 and will stay on this dose of olmesartan once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP will be allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696 matching placebo) and 1 capsule (olmesartan
Study Arm Type:Experimental
Arm Name:LCZ696 Regimen
Description:Randomized patients will receive LCZ696 once daily for four weeks, then will be force-titrated to a higher dose at Week 4 and will stay on this dose of LCZ696 once daily for the remainder of the treatment period. At week 12, patients with uncontrolled BP will be allowed to have amlodipine then hydrochlorothiazide (HCTZ) added at intervals of 4 weeks from Week 12 up to Week 24. To maintain the double dummy, double-blind design, 2 tablets (LCZ696, its matching placebo) and 1 capsule (olmesartan ma

Study Agencies

Agency Class:Industry
Agency Type:Lead Sponsor
Agency Name:Novartis Pharmaceuticals

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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