Study of the Efficacy and Safety of LCZ696 Alone and in Combination With Amlodipine in Patients With Hypertension

NCT ID: NCT01865188

Last Updated: 2014-08-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-04-30
• Study Completion Date: 2015-04-30

Brief Summary

To evaluate the blood pressure lowering effect and safety of LCZ696 when given alone and in combination with amlodipine in patients with essential hypertension.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

LCZ696 200 mg

Patients randomized to this treatment arm will receive LCZ696 200 mg once daily for 8 weeks.

Group Type: EXPERIMENTAL

LCZ696

Intervention Type: DRUG

Experimental monotherapy doses

LCZ696 400 mg

Patients randomized to this treatment arm will receive LCZ696 400 mg once daily for 8 weeks.

Group Type: EXPERIMENTAL

LCZ696

Intervention Type: DRUG

Experimental monotherapy doses

Amlodipine 5 mg

Patients randomized to this treatment arm will receive amlodipine 5 mg once daily for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

Active comparator monotherapy doses

Amlodipine 10 mg

Patients randomized to this treatment arm will receive amlodipine 10 mg once daily for 8 weeks.

Group Type: ACTIVE_COMPARATOR

Amlodipine

Intervention Type: DRUG

Active comparator monotherapy doses

LCZ696 200 mg and amlodipine 5 mg

Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 8 weeks.

Group Type: EXPERIMENTAL

LCZ696 and amlodipine combination

Intervention Type: DRUG

Experimental combination doses

LCZ696 200 mg and amlodipine 10 mg

Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 1 week followed by LCZ696 200 mg and amlodipine 10 mg once daily for 7 weeks.

Group Type: EXPERIMENTAL

LCZ696 and amlodipine combination

Intervention Type: DRUG

Experimental combination doses

LCZ696 400 mg and amlodipine 5 mg

Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 1 week followed by LCZ696 400 mg and amlodipine 5 mg once daily for 7 weeks.

Group Type: EXPERIMENTAL

LCZ696 and amlodipine combination

Intervention Type: DRUG

Experimental combination doses

LCZ696 400 mg and amlodipine 10 mg

Patients randomized to this treatment arm will receive LCZ696 200 mg and amlodipine 5 mg once daily for 1 week followed by LCZ696 400 mg and amlodipine 10 mg once daily for 7 weeks.

Group Type: EXPERIMENTAL

LCZ696 and amlodipine combination

Intervention Type: DRUG

Experimental combination doses

Placebo

Patients randomized to this treatment arm will receive placebo once daily for 8 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo comparator dose

Interventions

LCZ696

Experimental monotherapy doses

Intervention Type: DRUG

Amlodipine

Active comparator monotherapy doses

Intervention Type: DRUG

LCZ696 and amlodipine combination

Experimental combination doses

Intervention Type: DRUG

Placebo

Placebo comparator dose

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Male or female outpatients

2. Patients with mild-to-moderate hypertension, untreated or currently taking antihypertensive therapy

3. 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 and msSBP ≥140 mmHg <180 mmHg at the preceding visit.

4. 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 the randomization visit and the preceding visit.

5. Patients must have an absolute difference of ≤15 mmHg in msSBP between the randomization visit and the preceding visit.

6. Ability to communicate and comply with all study requirements and demonstrate good medication compliance (≥ 80% compliance rate) during the treatment run-in period.

Exclusion Criteria

1. Severe hypertension (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. Pregnant or lactating women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

2013-001643-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLCZ696A2320

Identifier Type: -

Identifier Source: org_study_id