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Valsartan/Amlodipine As Compared to Losartan Treatment in Stage 2 Systolic Hypertension (EXALT)

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ClinicalTrials.gov Identifier: NCT00931710
Recruitment Status : Completed
First Posted : July 2, 2009
Results First Posted : February 4, 2011
Last Update Posted : March 7, 2011
Sponsor:
Information provided by:
Novartis

Study Description
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Brief Summary:
This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 mmHg).

Condition or disease Intervention/treatment Phase
Stage 2 Systolic Hypertension Drug: valsartan, amlodipine, HCTZ Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 488 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension
Study Start Date : July 2009
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Valsartan/amlodipine/HCTZ
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
 Drug: valsartan, amlodipine, HCTZ
combination Valsartan/amlodipine160/5 mg tablet for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (6 weeks) of the study
Active Comparator: Losartan/HCTZ
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
 Drug: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ
losartan 100mg capsule for 3 weeks; losartan 100mg capsule +HCTZ 25 mg capsule for 3 weeks; Valsartan/amlodipine 160/5mg tablet +HCTZ 25 mg capsule for 3 weeks; valsartan/amlodipine 320/10 mg tablet + HCTZ 25mg capsule for remainder (3 weeks) of the study


Outcome Measures
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Primary Outcome Measures :
  1. Change in Mean Sitting Systolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ]
    To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.


Secondary Outcome Measures :
  1. Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks [ Time Frame: Baseline to Week 6 ]
    To compare the change from baseline in mean sitting diastolic blood pressure (MSDBP) after 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.

  2. Cumulative Percentage of Patients Achieving Blood Pressure Control [ Time Frame: 3 and 6 weeks ]
    To compare the percentage of patients achieving blood pressure control (defined as patients achieving MSSBP < 140 mmHg and MSDBP < 90 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.

  3. Cumulative Percentage of Treatment Responders [ Time Frame: 3 and 6 weeks ]
    To compare the percentage of treatment responders (defined as patients with MSSBP < 140 mmHg or demonstrating a decrease from baseline of ≥ 20 mmHg) after 3 and 6 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.

  4. Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks [ Time Frame: Baseline to week 12 ]
    To compare the change from baseline in MSSBP and MSDBP after 12 weeks of valsartan/amlodipine-based regimen with losartan-based regimen in patients with Stage 2 systolic hypertension.

  5. Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit [ Time Frame: 3, 6, 9 and 12 weeks ]
    To assess the incidence of peripheral edema occurring with valsartan/amlodipine-based regimen versus losartan-based regimen in patients with Stage 2 systolic hypertension.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female outpatient of 18 years of age or greater
  • Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and < 200 mmHg at randomization
  • Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.

Exclusion Criteria:

  • Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit 1.
  • Use of four (4) or more antihypertensive medications within 30 days of Visit 1.
  • Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
  • Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations
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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): NCT00931710


Locations
United States, New Jersey
sites in USA
East Hanover, New Jersey, United States
Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals 862-778-8300
More Information
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Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00931710     History of Changes
Other Study ID Numbers: CVEA489AUS01
First Posted: July 2, 2009    Key Record Dates
Results First Posted: February 4, 2011
Last Update Posted: March 7, 2011
Last Verified: March 2011

Keywords provided by Novartis:
Hypertension
combination therapy
valsartan
cardiovascular diseases

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Amlodipine
Valsartan
Losartan
Hydrochlorothiazide
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
 Molecular Mechanisms of Pharmacological Action
Vasodilator Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Anti-Arrhythmia Agents
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors