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Completed

NCT Number: NCT00760266

Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older Population

The purpose of the study is to evaluate the efficacy and safety of initial use of a fixed dose combination of aliskiren Hydrochlorothiazide (HCTZ) compared to Hydrochlorothiazide in older population with Stage 2 systolic hypertension.

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Key information

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sites in USA

East Hanover, New Jersey, 07936, 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 outpatients, ≥ 55 years old
  • Patients with essential hypertension
  • Prior to randomization: Patients must have an office cuff mean sitting Systolic Blood Pressure ≥ 160 mm Hg and < 200 mm Hg
  • Patients who are eligible and able to participate in the study, and who are willing to give informed consent before any assessment is performed

Exclusion criteria

  • Office blood pressure measured by cuff (msSBP ≥ 200 mm Hg and/or msDBP ≥ 110 mm Hg) at Visits 1-5
  • History or evidence of a secondary hypertension of any etiology (e.g., uncorrected renal artery stenosis, pheochromocytoma).
  • History of hypertensive encephalopathy or heart failure (New York Heart Association [NYHA] Class II-IV)
  • Cerebrovascular accident, transient ischemic cerebral attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI) within 1 year prior to Visit 1
  • Serum sodium less than the lower limit of normal, serum potassium < 3.5 mEq/L (corresponding to 3.5 mmol/L) or ≥ 5.3 mEq/L (corresponding to 5.3 mmol/L), or dehydration at Visit 1.
  • Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test (> 5 mIU/mL)
  • Use of other investigational drugs within 30 days of enrollment.

Other exclusions may apply.

Treatment and study plan

Aliskiren

Drug

Aliskiren 150 mg for 1 week, Aliskiren 300 mg (with or without amlodipine)for 7 weeks

Hydrochlorothiazide

Drug

Hydrochlorothiazide (HCTZ) 12.5 mg for week 1; Hydrochlorothiazide (HCTZ) 25 mg (with or without amlodipine)for 7 weeks

Primary outcomes

  1. Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to Week 4

    Time frame: Baseline and Week 4

Secondary outcomes

  1. Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to Week 4

    Time frame: Baseline and Week 4

  2. Change in Mean Sitting Systolic Blood Pressure (msSBP) and Mean Sitting Diastolic Blood Pressure (msDBP) (in Patients With msDBP ≥90 mmHg at Baseline) From Baseline to Week 8

    Time frame: Baseline and Week 8

  3. Percentage of Responders at Week 4 and Week 8

    Time frame: At 4 weeks and 8 weeks

    Responders defined as mean sitting Systolic Blood Pressure < 140 mmHg or reduction of ≥ 20 mmHg from baseline

  4. Percentage of Subjects Achieving Blood Pressure Control at Weeks 4 and 8

    Time frame: At Weeks 4 and 8

    Blood pressure control defined as mean sitting Systolic Blood Pressure < 140 mm Hg and mean sitting Diastolic Blood Pressure < 90 mm Hg

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

An 8-week Randomized, Double-blind, Parallel-group, Multi-center, Active-controlled Dose Escalation Study to Evaluate the Efficacy and Safety of Aliskiren HCTZ (300/25 mg) Compared to HCTZ (25 mg) in Older Patients With Stage 2 Systolic Hypertension

Acronym: ACTION

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 26, 2008
Registry last updated
Apr 4, 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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