Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine

NCT01663233 | Completed Phase 3 Results DMC

• 1 other identifier: CLCZ696A2319
• Study Type: interventional
• Target: 266
• Locations: 6 countries
• Sites: 28

Brief Summary

This study will assess whether LCZ696 when used in combination with amlodipine will provide greater BP lowering benefit compared to amlodipine alone in Asian hypertensive patients not adequately responsive to amlodipine therapy.

Conditions

Essential Hypertension

Keywords

Essential hypertension; High blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in Mean 24-hour Ambulatory Blood Pressure Monitoring (ABPM) Systolic Blood Pressure (maSBP)

  The change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups was measured. A greater reduction from baseline in the LCZ696 group indicates a positive treatment effect.

  8 weeks

Secondary Outcomes (8)

• Change in Mean 24-hour ABPM Diastolic Blood Pressure (maDBP)

  8 weeks

• Change in Mean Sitting Systolic Blood Pressure (msSBP)

  8 weeks

• Change in Mean Sitting Diastolic Blood Pressure (msDBP)

  8 weeks

• Change in Sitting Pulse Pressure (PP)

  8 weeks

• Number of Participants Achieving Systolic and Diastolic Blood Pressure Control (< 140/90 mmHg)

  8 weeks

Study Arms (2)

LCZ696 and amlodipine

EXPERIMENTAL

Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.

Drug: LCZ696; Drug: Amlodipine

Amlodipine

ACTIVE COMPARATOR

Participants, first treated with 5 mg of amlodipine for 4 weeks to determine if they were not adequately responding to amlodipine (had an office msSBP ≥145 mmHg and \<180 mmHg) and who met all inclusion and exclusion criteria), were randomized to receive 5 mg of amlodipine and placebo to LCZ696 for 8 weeks.

Drug: Amlodipine; Drug: Placebo

Interventions

LCZ696 DRUG

LCZ696 will use tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.

LCZ696 and amlodipine

Amlodipine DRUG

Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.

Amlodipine; LCZ696 and amlodipine

Placebo DRUG

Matching placebo to LCZ696

Amlodipine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must give written informed consent and have a diagnosis of hypertension:
• Untreated patients must have an msSBP ≥ 150 mmHg and \< 180 mmHg at both Visit 1 and Visit 101. Pre-treated patients must have an msSBP ≥ 145 mmHg and \< 180 mmHg after wash out at Visit 101. All patients must have an office msSBP ≥ 145 mmHg and \< 180 mmHg at the completion of the 4-week run-in epoch (at the randomization visit (Visit 201).
• Patients must successfully complete ABPM and pass technical requirements at Visit 201.

You may not qualify if:

• 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. Transient ischemic cerebral attack (TIA) during the 12 months prior to Visit 1 or any history of stroke.
• History of myocardial infarction, coronary bypass surgery or PCI during the 12 months prior to Visit 1

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (28)

Novartis Investigative Site

Shijiazhuang, Hebei, 050000, China

Location

Novartis Investigative Site

Chongqing, 400042, China

Location

Novartis Investigative Site

Shanghai, 200025, China

Location

Novartis Investigative Site

Tianjin, 300142, China

Location

Novartis Investigative Site

Edogawa-ku, Tokyo, 133-0061, Japan

Location

Novartis Investigative Site

Katsushika-ku, Tokyo, 124-0024, Japan

Location

Novartis Investigative Site

Kiyose, Tokyo, 204-0021, Japan

Location

Novartis Investigative Site

Kunitachi, Tokyo, 186-0001, Japan

Location

Novartis Investigative Site

Shibuya-ku, Tokyo, 150-0002, Japan

Location

Novartis Investigative Site

Shinagawa-ku, Tokyo, 142-0063, Japan

Location

Novartis Investigative Site

Toshima-ku, Tokyo, 171-0021, Japan

Location

Novartis Investigative Site

Kuching, Sarawak, 94300, Malaysia

Location

Novartis Investigative Site

Kuala Lumpur, 56000, Malaysia

Location

Novartis Investigative Site

Quezon City, Manila, 1100, Philippines

Location

Novartis Investigative Site

Manila, National Capital Region, 1000, Philippines

Location

Novartis Investigative Site

Quezon City, 1100, Philippines

Location

Novartis Investigative Site

Quezon City, 1102, Philippines

Location

Novartis Investigative Site

Valenzuela, 1441, Philippines

Location

Novartis Investigative Site

Busan, Busan, 602-739, South Korea

Location

Novartis Investigative Site

Wŏnju, Gangwon-do, 220-701, South Korea

Location

Novartis Investigative Site

Koyang, Kyunggi, 410-719, South Korea

Location

Novartis Investigative Site

Seoul, Seoul, 150-713, South Korea

Location

Novartis Investigative Site

Daegu, 705-703, South Korea

Location

Novartis Investigative Site

Daegu, 705-718, South Korea

Location

Novartis Investigative Site

Taichung, Taiwan, 40447, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 10002, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, 114, Taiwan

Location

Novartis Investigative Site

Taipei, Taiwan, ROC, 112, Taiwan

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

sacubitril and valsartan sodium hydrate drug combination; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

+1 (862) 778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2012
• First Posted: August 13, 2012
• Study Start: August 1, 2012
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: October 23, 2015
• Results First Posted: August 18, 2015

Record last verified: 2015-10

Locations

PH (5); CN (4); KR (6); TW (4); JP (7); MY (2)