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Trial record 56 of 134 for:    OLMESARTAN

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

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ClinicalTrials.gov Identifier: NCT01599104
Recruitment Status : Completed
First Posted : May 15, 2012
Results First Posted : August 6, 2015
Last Update Posted : October 16, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: LCZ696 Drug: Olmesartan Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1161 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Study Start Date : June 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: LCZ696 200 mg
LCZ696 200 mg tablet and placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) tablet once daily for 8 weeks
Drug: LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily

Drug: Placebo
Placebo to LCZ696 or Olmesartan

Experimental: LCZ696 400 mg
LCZ696 200 mg tablet and a placebo to both LCZ696 (1 tablet) and Olmesartan (1 capsule) once daily for one week; then up-titrated to LCZ696 400 mg and placebo to Olmesartan (1 capsule) once daily for the remaining 7 weeks
Drug: LCZ696
200 mg (one tablet) or 400 mg (2 tablets of 200mg) once daily

Drug: Placebo
Placebo to LCZ696 or Olmesartan

Active Comparator: Olmesartan 20 mg
Olmesartan 20 mg capsule and placebo to LCZ696 (2 tablets) once daily for 8 weeks
Drug: Olmesartan
Olmesartan 20 mg capsule one daily

Drug: Placebo
Placebo to LCZ696 or Olmesartan




Primary Outcome Measures :
  1. Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP) [ Time Frame: Baseline, 8 weeks ]
    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.


Secondary Outcome Measures :
  1. Change From Baseline in Mean 24-hour Ambulatory SBP (maSBP) at Week 8 [ Time Frame: Baseline, 8 weeks ]
    Ambulatory blood pressure monitoring (ABPM) over a 24-hour period was conducted at two time-points during the study in a subset of participants.

  2. Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP) [ Time Frame: Baseline, 8 weeks ]
    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.

  3. Percentage of Participants Achieving a Successful Response in Overall Blood Pressure Control at Week 8 [ Time Frame: 8 weeks ]
    A successful response in overall BP control rate was defined as msSBP < 140 mmHg and msDBP <90 mmHg.

  4. Percentage of Participants Achieving a Successful msSBP Response [ Time Frame: 8 weeks ]
    Successful msSBP response was defined as < 140 mmHg or ≥ 20 mmHg reduction from baseline.

  5. Percentage of Participants Achieving a Successful msDBP Response [ Time Frame: 8 weeks ]
    Successfull msDBP response was defined as <90 mmHg or ≥10 mmHg reduction from baseline.

  6. Change From Baseline in Mean 24-hour Ambulatory DBP (maDBP) at Week 8 [ Time Frame: Baseline, 8 weeks ]
    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.

  7. Change From Baseline in maSBP and maDBP for Daytime/Nighttime [ Time Frame: Baseline, 8 weeks ]
    ABPM over a 24-hour period was conducted at two time-points during the study in a subset of participants.

  8. Change From Baseline in Office Pulse Pressure [ Time Frame: Baseline, 8 weeks ]
    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.

  9. Change From Baseline in Mean 24-hour Ambulatory Pulse Pressure [ Time Frame: Baseline, 8 weeks ]
    Ambulatory pulse pressure was calculated as hourly ambulatory SBP minus hourly ambulatory DBP in a subset of participants.

  10. Number of Patients With Adverse Events, Serious Adverse Events and Death [ Time Frame: 8 weeks ]
    Participants were monitored for adverse events, serious adverse events and deaths throughout the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599104


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Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01599104     History of Changes
Other Study ID Numbers: CLCZ696A1306
First Posted: May 15, 2012    Key Record Dates
Results First Posted: August 6, 2015
Last Update Posted: October 16, 2015
Last Verified: September 2015
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
Essential hypertension
LCZ696
Additional relevant MeSH terms:
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Olmesartan
Olmesartan Medoxomil
Hypertension
Essential Hypertension
Vascular Diseases
Cardiovascular Diseases
LCZ 696
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action