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

Essential Hypertension Clinical Trial

Official 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 Japanese Patients With Essential Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01599104
• Other study ID #: CLCZ696A1306
• Status: Completed
• Phase: Phase 3
• First received: May 13, 2012
• Last updated: September 25, 2015
• Start date: June 2012
• Est. completion date: April 2013

Study information

• Verified date: September 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

This study assessed the efficacy of LCZ696 in Japanese patients with essential hypertension

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1161
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years and older

Eligibility

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 proceeding 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:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Essential Hypertension
• Hypertension

Intervention

Drug:
• LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily
• Olmesartan
Olmesartan 20 mg capsule one daily
• Placebo
Placebo to LCZ696 or Olmesartan

Locations

Country	Name	City	State
Japan	Novartis Investigative Site	Ageo-city	Saitama
Japan	Novartis Investigative Site	Amagasaki	Hyogo
Japan	Novartis Investigative Site	Asahikawa	Hokkaido
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Bunkyo-ku	Tokyo
Japan	Novartis Investigative Site	Chikushi-gun	Fukuoka
Japan	Novartis Investigative Site	Chiyoda-ku	Tokyo
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Edogawa-ku	Tokyo
Japan	Novartis Investigative Site	Fujimino	Saitama
Japan	Novartis Investigative Site	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Fukuoka-city	Fukuoka
Japan	Novartis Investigative Site	Hachioji	Tokyo
Japan	Novartis Investigative Site	Hachioji-city	Tokyo
Japan	Novartis Investigative Site	Hiki-Gun	Saitama
Japan	Novartis Investigative Site	Hitachi-city	Ibaraki
Japan	Novartis Investigative Site	Ibadraki	Osaka
Japan	Novartis Investigative Site	Kamogawa-City	Chiba
Japan	Novartis Investigative Site	Kashihara-city	Nara
Japan	Novartis Investigative Site	Katsushika-ku	Tokyo
Japan	Novartis Investigative Site	Kawasaki-city	Kanagawa
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kitakyushu-city	Fukuoka
Japan	Novartis Investigative Site	Kiyose-city	Tokyo
Japan	Novartis Investigative Site	Koshigaya city	Saitama
Japan	Novartis Investigative Site	Kunitachi	Tokyo
Japan	Novartis Investigative Site	Kyotanabe-city	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Kyoto-city	Kyoto
Japan	Novartis Investigative Site	Meguro-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Minato-ku	Tokyo
Japan	Novartis Investigative Site	Nerima-ku	Tokyo
Japan	Novartis Investigative Site	Niiza-city	Saitama
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka
Japan	Novartis Investigative Site	Osaka-city	Osaka
Japan	Novartis Investigative Site	Ota-ku	Tokyo
Japan	Novartis Investigative Site	Saitama
Japan	Novartis Investigative Site	Sakado	Saitama
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Sapporo-city	Hokkaido
Japan	Novartis Investigative Site	Shibuya-ku	Tokyo
Japan	Novartis Investigative Site	Shimotsuke-city	Tochigi
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinagawa-ku	Tokyo
Japan	Novartis Investigative Site	Shinjuku-ku	Tokyo
Japan	Novartis Investigative Site	Tachikawa	Tokyo
Japan	Novartis Investigative Site	Taito	Tokyo
Japan	Novartis Investigative Site	Tokorozawa-city	Saitama
Japan	Novartis Investigative Site	Toshima-ku	Tokyo
Japan	Novartis Investigative Site	Toyonaka-city	Osaka
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa
Japan	Novartis Investigative Site	Yokohama-city	Kanagawa

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)	Sitting BP measurements were performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurements. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.	Baseline, 8 weeks	No
Secondary	Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8	Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.	Baseline, 8 weeks	No
Secondary	Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)	Sitting BP measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and averaged, and then the baseline BP value was subtracted from the average value to get the change from baseline.	Baseline, 8 weeks	No
Secondary	Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8	A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.	8 weeks	No
Secondary	Percentage of Participants Achieving a Successful msSBP Response	Successful msSBP response was defined as < 140 mmHg or = 20 mmHg reduction from baseline.	8 weeks	No
Secondary	Percentage of Participants Achieving a Successful msDBP Response	Successfull msDBP response was defined as <90 mmHg or =10 mmHg reduction from baseline.	8 weeks	No
Secondary	Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8	ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.	Baseline, 8 weeks	No
Secondary	Change From Baseline in maSBP and maDBP for Daytime/Nighttime	ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.	Baseline, 8 weeks	No
Secondary	Change From Baseline in Office Pulse Pressure	Office pulse pressure was calculated as msSBP minus msDBP. Sitting blood pressure (BP) measurement was performed at screening through the end of study at every visit. Four separate sitting BP were obtained with a full two-minute interval between measurement. The 4 measurements were summed and then averaged to calculate the mean BP value. The baseline PP value was subtracted from the week 8 PP value to determine the change from baseline in PP.	Baseline, 8 weeks	No
Secondary	Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure	Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.	Baseline, 8 weeks	No
Secondary	Number of Patients With Adverse Events, Serious Adverse Events and Death	Participants were monitored for adverse events, serious adverse events and deaths throughout the study.	8 weeks	Yes