Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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 has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01663233
First received: August 8, 2012
Last updated: August 29, 2013
Last verified: August 2013

August 8, 2012
August 29, 2013
August 2012
May 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01663233 on ClinicalTrials.gov Archive Site
  • 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.
  • 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 deemed 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 treament ] [ 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.
Not Provided
Not Provided
 
Efficacy and Safety of LCZ696 200 mg + Amlodipine 5 mg in Comparison With Amlodipine 5 mg in Hypertensive Patients Not Responding to Amlodipine
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Essential Hypertension
  • 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.
  • 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.
    Interventions:
    • Drug: LCZ696
    • Drug: Amlodipine
  • 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.
    Intervention: Drug: Amlodipine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
266
May 2013
May 2013   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
China,   Japan,   Korea, Republic of,   Malaysia,   Philippines,   Taiwan
 
NCT01663233
CLCZ696A2319
Yes
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP