Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine
This study is currently recruiting participants.
Verified May 2013 by Novartis
Sponsor:
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01663233
First received: August 8, 2012
Last updated: May 21, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Essential Hypertension |
Drug: LCZ696 Drug: Amlodipine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, 8-week, Double-blind, Parallel-group, Active-controlled, Multicenter Study to Evaluate the Efficacy and Safety of the Combination of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Patients With Essential Hypertension Not Adequately Responsive to Amlodipine 5 mg Monotherapy Treatment |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Change in mean 24-hour ABPM systolic blood pressure (maSBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measure the change in mean 24 hour ambulatory systolic blood pressure (maSBP) from baseline to end of the study (week 8) in the 2 groups. A greater reduction from baseline in the LCZ696 group will indicate whether there is a positive treatment effect.
Secondary Outcome Measures:
- Change in mean 24-hour ABPM diastolic blood pressure (maDBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measure the change in mean 24 hour ambulatory diastolic blood pressure (maDBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect.
- Change in mean sitting systolic blood pressure (msSBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measure the change in the patient's mean sitting systolic blood pressure (msSBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect.
- Change in mean sitting diastolic blood pressure (msDBP) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measure the change in the patient's mean sitting diastolic blood pressure (msDBP) from baseline to end of the study. A reduction from baseline will indicate whether there is a positive treatment effect.
- Change in sitting pulse pressure [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]Measure the change in the patient's mean sitting pulse pressure from baseline to end of the study. Pulse pressure measures the difference in mean sitting systolic blood pressure and mean sitting diastolic blood pressure.
- Percentage of patients achieving systolic and diastolic blood pressure control (< 140/90 mmHg) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The Percentage of patients achieving a systolic and diastolic blood pressure < 140/90 mmHg is a measure of how well a given blood pressure treatment can achieve a given blood pressure target or goal. Patient that achieve the target blood pressure will be determined based on the mean sitting diastolic and systolic blood measurements taken at the end of the study. If the patient BP measurement is below the above target they will be considered as a success.
- Percentage of patients achieving successful response in msSBP (< 140 mmHg or a reduction ≥ 20 mmHg from baseline) [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]The percentage of patients that achieve successful treatment response in the mean sitting systolic blood pressure (msSBP) of < 140mmHg or a reduction ≥ 20 mmHg from baseline after completing study treatment. Patients that achieve either of the above targets will be deemed as a having a successful response.
- Percentage of patients achieving successful response in msDBP (< 90 mmHg or a reduction ≥ 10 mmHg from baseline) [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]The percentage of patients that achieve successful treatment response in the mean sitting diastolic blood pressure (msDBP) of < 90mmHg or a reduction ≥ 10mmHg from baseline after completing study treatment. Patients that achieve either of the above targets will be deemed as having a successful response.
- Number of patients with adverse event [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]Summarized statistics on adverse events will be reported under categories such as total adverse events, serious adverse events and death.
| Estimated Enrollment: | 236 |
| Study Start Date: | August 2012 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: LCZ696 and amlodipine
118 patients will first be treated to receive 5 mg of amlodipine for 4 weeks to deter if that they are not adequately responding to amlodipine (must have a systolic BP >/= 145mmHg and meet all inclusion and exclusion criteria) will be randomized to receive 200mg of LCZ696 in combination with 5 mg of amlodipine for 8 weeks.
|
Drug: LCZ696
LCZ696 will used tablets available at a strength of 200mg. Patients will be instructed to take the prescribed medication once a day.
Drug: Amlodipine
Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.
|
|
Active Comparator: Amlodipine
118 patients will first be treated to receive 5 mg of amlodipine for 4 weeks to determine if that they are not adequately responding to amlodipine (must have a systolic BP >/= 145mmHg and meet all inclusion and exclusion criteria) will be randomized to receive 5 mg and placebo to LCZ696 for 8 weeks.
|
Drug: Amlodipine
Amlodipine will use tablets available at a strength of 5 mg. Patients will be instructed to take the prescribed medication once a day.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Patients must 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.
Exclusion Criteria:
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
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01663233
Contacts
| Contact: Novartis Pharmaceuticals | +41613241111 | |
| Contact: Novartis Pharmaceuticals |
Locations
| China, Hebei | |
| Novartis Investigative Site | Recruiting |
| Shijiazhuang, Hebei, China, 050000 | |
| China | |
| Novartis Investigative Site | Recruiting |
| Chongqing, China, 400042 | |
| Novartis Investigative Site | Recruiting |
| Shanghai, China, 200025 | |
| Novartis Investigative Site | Recruiting |
| Tianjin, China, 300142 | |
| Japan | |
| Novartis Investigative Site | Active, not recruiting |
| Edogawa-ku, Tokyo, Japan, 133-0061 | |
| Novartis Investigative Site | Completed |
| Katsushika-ku, Tokyo, Japan, 124-0024 | |
| Novartis Investigative Site | Completed |
| Kiyose, Tokyo, Japan, 204-0021 | |
| Novartis Investigative Site | Completed |
| Kunitachi, Tokyo, Japan, 186-0001 | |
| Novartis Investigative Site | Completed |
| Shibuya-ku, Tokyo, Japan, 150-0002 | |
| Novartis Investigative Site | Completed |
| Shinagawa-ku, Tokyo, Japan, 142-0063 | |
| Novartis Investigative Site | Active, not recruiting |
| Toshima-ku, Tokyo, Japan, 171-0021 | |
| Korea, Republic of | |
| Novartis Investigative Site | Recruiting |
| Wonju, Gangwon-Do, Korea, Republic of, 220-701 | |
| Novartis Investigative Site | Completed |
| Koyang, Kyunggi, Korea, Republic of, 410-719 | |
| Novartis Investigative Site | Active, not recruiting |
| Busan, Korea, Republic of, 602-739 | |
| Novartis Investigative Site | Recruiting |
| Daegu, Korea, Republic of, 705-718 | |
| Novartis Investigative Site | Recruiting |
| Daegu, Korea, Republic of, 705-717 | |
| Novartis Investigative Site | Not yet recruiting |
| Seoul, Korea, Republic of, 156-707 | |
| Novartis Investigative Site | Active, not recruiting |
| Seoul, Korea, Republic of, 150-713 | |
| Malaysia | |
| Novartis Investigative Site | Recruiting |
| Kuching, Sarawak, Malaysia, 94300 | |
| Novartis Investigative Site | Recruiting |
| Kuala Lumpur, Malaysia, 56000 | |
| Philippines | |
| Novartis Investigative Site | Active, not recruiting |
| Manila, Philippines, 1000 | |
| Novartis Investigative Site | Withdrawn |
| Quezon City, Philippines, 1113 | |
| Novartis Investigative Site | Active, not recruiting |
| Quezon City, Philippines, 1102 | |
| Novartis Investigative Site | Active, not recruiting |
| Quezon City, Philippines, 1100 | |
| Novartis Investigative Site | Active, not recruiting |
| Valenzuela City, Philippines, 1441 | |
| Taiwan | |
| Novartis Investigative Site | Active, not recruiting |
| Taipei, Taiwan, ROC, Taiwan, 112 | |
| Novartis Investigative Site | Not yet recruiting |
| Changhua, Taiwan, 500 | |
| Novartis Investigative Site | Recruiting |
| Taichung, Taiwan, 40447 | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, 10002 | |
| Novartis Investigative Site | Recruiting |
| Taipei, Taiwan, 114 | |
| Novartis Investigative Site | Recruiting |
| Yun-Lin, Taiwan, 640 | |
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: | NCT01663233 History of Changes |
| Other Study ID Numbers: | CLCZ696A2319 |
| Study First Received: | August 8, 2012 |
| Last Updated: | May 21, 2013 |
| Health Authority: | Japan: Pharmaceuticals and Medical Devices Agency China: Food and Drug Administration Korea: Food and Drug Administration Malaysia: Ministry of Health Philippines: Bureau of Food and Drugs Taiwan: Center for Drug Evaluation |
Keywords provided by Novartis:
|
Essential hypertension High blood pressure |
Additional relevant MeSH terms:
|
Hypertension Vascular Diseases Cardiovascular Diseases Amlodipine Calcium Channel Blockers Membrane Transport Modulators |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Vasodilator Agents Antihypertensive Agents |
ClinicalTrials.gov processed this record on June 17, 2013