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Completed

NCT Number: NCT00931710

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

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).

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Key information

Conditions

Stage 2 Systolic Hypertension Cardiovascular Diseases Essential Hypertension Hypertension Isolated Systolic Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

sites in USA

East Hanover, New Jersey, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

valsartan, amlodipine, HCTZ

Drug

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

Losartan, HCTZ followed by valsartan, amlodipine, HCTZ

Drug

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study 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

Acronym: EXALT

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jul 2, 2009
Registry last updated
Mar 7, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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