Hypertension With Renal Dysfunction Clinical Trial
Official title:
A Multi-center, Open Label Study for Evaluation of the Safety, Tolerability and Efficacy of 8-week Treatment With LCZ696 in Japanese Hypertensive Patients With Renal Dysfunction
| Verified date | August 2015 |
| Source | Novartis |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Japan: Ministry of Health, Labor and Welfare |
| Study type | Interventional |
This study assessed the safety, tolerability, and efficacy of LCZ696 in hypertensive patients with renal dysfunction.
| Status | Completed |
| Enrollment | 32 |
| Est. completion date | March 2013 |
| Est. primary completion date | March 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Renal findings: Hypertensive patients with renal dysfunction and stable renal condition at least 4 weeks before screening visit. - Satisfy office msSBP =140 mmHg and <180 mmHg at baseline. Exclusion Criteria: - Patients show msDBP =110 mmHg and/or msSBP =180 mmHg. - History of angioedema, drug-related or otherwise, as reported by the patient. - Any other following renal disorder: - Patients show eGFR < 15mL/min/1.73m^2 - Patients on dialysis - 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. |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Japan | Novartis Investigative Site | Aira-city | Kagoshima |
| Japan | Novartis Investigative Site | Fujimino | Saitama |
| Japan | Novartis Investigative Site | Hachioji-city | Tokyo |
| Japan | Novartis Investigative Site | Kawasaki-city | Kanagawa |
| Japan | Novartis Investigative Site | Kurashiki | Okayama |
| Japan | Novartis Investigative Site | Minato-ku | Tokyo |
| Japan | Novartis Investigative Site | Osaka | |
| Japan | Novartis Investigative Site | Sapporo | Hokkaido |
| Japan | Novartis Investigative Site | Sapporo | Hokkaido |
| Japan | Novartis Investigative Site | Sapporo-city | Hokkaido |
| Japan | Novartis Investigative Site | Sendai-city | Miyagi |
| Japan | Novartis Investigative Site | Shinagawa-ku | Tokyo |
| Japan | Novartis Investigative Site | Yokohama-city | Kanagawa |
| Lead Sponsor | Collaborator |
|---|---|
| Novartis Pharmaceuticals |
Japan,
Ito S, Satoh M, Tamaki Y, Gotou H, Charney A, Okino N, Akahori M, Zhang J. Safety and efficacy of LCZ696, a first-in-class angiotensin receptor neprilysin inhibitor, in Japanese patients with hypertension and renal dysfunction. Hypertens Res. 2015 Apr;38(4):269-75. doi: 10.1038/hr.2015.1. Epub 2015 Feb 19. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Percentage of Participants With Reported Adverse Events (Total Adverse Events, Serious Adverse Events and Death) | Percentage of patients with total adverse events, serious adverse events and death were reported. | 8 weeks | Yes |
| Secondary | Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) at Week 8 | 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. | baseline, 8 weeks | No |
| Secondary | Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) at Week 8 | baseline, 8 weeks | No | |
| Secondary | Percentage of Participants Achieving a Successful BP Control at Week 8 | A successful BP control was defined as msSBP <130 mmHg and msDBP <80 mmHg | 8 weeks | No |
| Secondary | Percentage of Participants Achieving SBP Control at Week 8 | SBP control was defined as msSBP <130 mmHg. | 8 weeks | No |
| Secondary | Percentage of Participants Achieving DBP Control at Week 8 | DBP control was defined as msDBP <80 mmHg. | 8 weeks | No |
| Secondary | Percentage of Participants Achieving a Successful Response Rate in msSBP at Week 8 | Successful response rate was defined as msSBP <130 mmHg or a reduction of =20 mmHg from baseline | 8 weeks | No |
| Secondary | Percentage of Participants Achieving a Successful Response Rate in msDBP at Week 8 | Successful response rate was defined as msDBP <80 mmHg or a reduction of =10 mmHg from baseline. | 8 weeks | No |