Assessment of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension
This study is currently recruiting participants.
Verified April 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01681576
First received: August 30, 2012
Last updated: April 2, 2013
Last verified: April 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
This study will evaluate the effect of LCZ696 and valsartan on natriuresis, diuresis, and blood pressure in salt-sensitive Asian hypertensive patients.
| Condition | Intervention | Phase |
|---|---|---|
|
Salt-sensitive Hypertension |
Drug: Valsartan Drug: LCZ696 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
| Official Title: | A Randomized, Double-blind, Crossover Study to Assess the Effects of LCZ696 and Valsartan in Asian Patients With Salt-sensitive Hypertension |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Cumulative Sodium excretion (natriuresis) [ Time Frame: 6 hour following the first dose of LCZ696 and valsartan ] [ Designated as safety issue: No ]Urine will be collected in fractions of 0 to 6 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium
- Cumulative Sodium excretion (natriuresis) [ Time Frame: 24 hour following the first dose of LCZ696 and valsartan ] [ Designated as safety issue: No ]Urine will be collected in fractions of 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium
Secondary Outcome Measures:
- Number of patients with adverse events [ Time Frame: During 4 weeks treatment ] [ Designated as safety issue: Yes ]Summarized statistics on adverse events will be reported which will be categorized as total adverse events, serious adverse events and death.
- Cumulative Sodium excretion (natriuresis) [ Time Frame: After 4 weeks of treatment ] [ Designated as safety issue: No ]Urine will be collected in fractions of 0 to 6 hours and 6 to 24 hours post-dose. From each fraction, a sample will be drawn for analysis of sodium
- Urine Volume (Diuresis) [ Time Frame: During 6 and 24 hours post first dose and after 4 weeks of treatment ] [ Designated as safety issue: No ]Urine will be collected and volume measured in fractions of 0 to 6 hours and 6 to 24 hours post-dose first and last dose
- Pharmacokinetics of LCZ696 (AHU377, LBQ657, valsartan) and Valsartan: Observed maximum plasma concentration (Cmax) following drug administration [ Time Frame: Day 1 and day 28 of treatment ] [ Designated as safety issue: No ]Blood will be collected at intervals and plasma separated and analyzed
- Pharmacokinetics of LCZ696 (AHU377, LBQ657, valsartan) and Valsartan: Time to reach the maximum concentration after drug administration (Tmax) [ Time Frame: Day 1 and day 28 of treatment ] [ Designated as safety issue: No ]Blood will be collected at intervals and plasma separated and analyzed
- Pharmacokinetics of LCZ696 (AHU377, LBQ657, valsartan) and Valsartan:Area under the plasma concentration-time curve from time zero to 24 hours (AUC0-24 hours) [ Time Frame: Day 1 and day 28 of treatment ] [ Designated as safety issue: No ]Blood will be collected at intervals and plasma separated and analyzed
- Pharmacokinetics of LCZ696 and valsartan: Accumulation ratio between Day 28 and Day 1 [ Time Frame: Day 1 and day 28 of treatment ] [ Designated as safety issue: No ]Blood will be collected at intervals and plasma separated and analyzed and the ratio AUC-24 hr(Day28) / AUC-24 hr(Day1) calculated
- Mean seated blood pressure following 4 weeks of treatment [ Time Frame: Day 1 and day 28 of treatment ] [ Designated as safety issue: No ]Seating BP (systolic blood pressure (msSBP) and diastolic blood pressure (msDBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.
- Mean arterial pressure (MAP) after following 4 weeks of treatment [ Time Frame: Day 1 and day 28 of treatment ] [ Designated as safety issue: No ]Seating BP (systolic blood pressure (msSBP) and diastolic blood pressure (msDBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.
- Mean siting pulse pressure after 4 weeks of treatment. [ Time Frame: Day 1 and day 28 of treatment ] [ Designated as safety issue: No ]Seating BP (systolic blood pressure (msSBP) and diastolic blood pressure (msDBP))measurements will be performed at trough(immediately prior to dosing at the clinic). Arterial BP readings will be made with an automated BP device.
| Estimated Enrollment: | 56 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | September 2013 |
| Estimated Primary Completion Date: | September 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Valsartan followed by LCZ696
Period 1: 4 weeks treatment with valsartan, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with LCZ696
|
Drug: Valsartan
Valsartan tablet once daily
Drug: LCZ696
LCZ696 tablet once daily
|
|
Experimental: LCZ696 followed by Valsartan
Period 1: 4 weeks treatment with LCZ696, 1-2 weeks wash-out, followed by period 2, 4 weeks treatment with valsartan
|
Drug: Valsartan
Valsartan tablet once daily
Drug: LCZ696
LCZ696 tablet once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Written informed consent must be obtained before any study assessment is performed.
- Males and females of non-childbearing potential and of legal age (at least 18 years or older as defined by local law).
- Asian patients with mild to moderate essential hypertension, untreated or currently taking antihypertensive therapy with up to two drugs.
Key Exclusion Criteria:
- Women of child-bearing potential.
- History of angioedema, drug-related or otherwise
- History of hypersensitivity to LCZ696, valsartan, or drugs of similar chemical classes.
- Severe hypertension (grade 3 of WHO classification; msDBP ≥100 mmHg and/or msSBP ≥ 180 mmHg) at screening or at the end of the washout period.
- History or evidence of a secondary form of hypertension,
- Transient ischemic cerebral attack (TIA) during the 12 months prior to screening or any history of stroke.
- History of myocardial infarction, coronary bypass surgery or percutaneous coronary intervention (PCI) during 12 month prior to screening.
- Current or history of hypertensive retinopathy.
- Previous or current diagnosis of heart failure (NYHA Class II-IV).
- Clinically significant valvular heart disease at screening.
Other protocol defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681576
Contacts
| Contact: Novartis Pharmaceuticals | 1-888-669-6682 | |
| Contact: Novartis Pharmaceuticals |
Locations
| United States, California | |
| Novartis Investigative Site | Recruiting |
| Anaheim, California, United States, 92801 | |
| Novartis Investigative Site | Not yet recruiting |
| Cypress, California, United States, 90630 | |
| Novartis Investigative Site | Not yet recruiting |
| Glendale, California, United States, 91206 | |
| United States, Florida | |
| Novartis Investigative Site | Not yet recruiting |
| Miramar, Florida, United States, 33025 | |
| Hong Kong | |
| Novartis Investigative Site | Not yet recruiting |
| Hong Kong, Shatin, NT, Hong Kong | |
| Korea, Republic of | |
| Novartis Investigative Site | Recruiting |
| Bucheon, Gyeonggi-do, Korea, Republic of, 424-717 | |
| Novartis Investigative Site | Recruiting |
| Koyang-si, Gyeonggi-do, Korea, Republic of, 410-773 | |
| Novartis Investigative Site | Recruiting |
| Seoul, Korea, Korea, Republic of, 110 744 | |
| Novartis Investigative Site | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Novartis Investigative Site | Recruiting |
| Seoul, Korea, Republic of, 152-703 | |
| Singapore | |
| Novartis Investigative Site | Recruiting |
| Singapore, Singapore, 168752 | |
| Novartis Investigative Site | Recruiting |
| Singapore, Singapore, 119228 | |
| Taiwan | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, ROC, Taiwan, 112 | |
| Novartis Investigative Site | Recruiting |
| Taichung, Taiwan, 40447 | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, 10002 | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, 114 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01681576 History of Changes |
| Other Study ID Numbers: | CLCZ696A2222 |
| Study First Received: | August 30, 2012 |
| Last Updated: | April 2, 2013 |
| Health Authority: | United States: Food and Drug Administration Korea: Food and Drug Administration Taiwan: Department of Health Singapore: Health Sciences Authority Hong Kong: Ethics Committee |
Keywords provided by Novartis:
|
hypertension, salt sensitivity, valsartan, LCZ696 |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Valsartan Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antihypertensive Agents Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013