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A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly

This study has been completed.
Sponsor:
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00368277
First received: August 22, 2006
Last updated: February 28, 2011
Last verified: February 2011

August 22, 2006
February 28, 2011
September 2006
February 2008   (final data collection date for primary outcome measure)
Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
Mean Sitting Systolic Blood Pressure lowering effect at baseline, week 12, week 36
Complete list of historical versions of study NCT00368277 on ClinicalTrials.gov Archive Site
  • Percentage of Patients With Cough [ Time Frame: Weeks 12 and 36 ] [ Designated as safety issue: Yes ]
  • Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints [ Time Frame: Weeks 12 and 36 ] [ Designated as safety issue: No ]
    Blood pressure control is defined as a mean sitting blood pressure < 140/90 mm Hg
  • Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36 [ Time Frame: Baseline and week 36 ] [ Designated as safety issue: No ]
  • Mean sitting diastolic blood pressure (msDBP) lowering from baseline to week 12, week 36
  • Cough at 12 and 36 weeks
  • Adverse Events at 12 and 36 weeks
  • Quality of Life at 12 and 36 weeks as assessed by the Psychological General Well-Being Index (PGWBI) and the Medical Outcomes Study (MOS) Sleep Scale (Short Form
  • Safety and tolerability
Not Provided
Not Provided
 
A Safety and Efficacy Trial of Aliskiren 150mg , 300 mg Compared to Ramipril 5mg, 10mg in the Elderly
A 36 Week Randomized, Double-blind, Parallel Group, Multi-center, Active-controlled, Optional Titration Study Comparing an Aliskiren-based Regimen to a Ramipril-based Regimen in Patients ≥ 65 Years Old With Systolic Essential Hypertension

Evaluate the systolic blood pressure lowering effect of aliskiren 150mg and 300mg compared to ramipril 5mg and 10mg in elderly patients with essential systolic hypertension.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Hypertension
  • Drug: Aliskiren
    Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning
  • Drug: Ramipril
    Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning
  • Drug: Hydrochlorothiazide
    Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning
  • Drug: Amlodipine
    Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning
  • Experimental: Aliskiren-based regimen
    Aliskiren 150 mg; aliskiren 300 mg; aliskiren 300mg + hydrochlorothiazide 12.5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; aliskiren 300 mg + hydrochlorothiazide 25 mg + amlodipine 10 mg
    Interventions:
    • Drug: Aliskiren
    • Drug: Hydrochlorothiazide
    • Drug: Amlodipine
  • Active Comparator: Ramipril-based regimen
    Ramipril 5 mg; Ramipril 10 mg; Ramipril 10 mg + hydrochlorothiazide 12.5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 5 mg; Ramipril 10 mg + hydrochlorothiazide 25 mg + amlodipine 10mg
    Interventions:
    • Drug: Ramipril
    • Drug: Hydrochlorothiazide
    • 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
901
February 2008
February 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Male or female outpatients ≥ 65 years old.
  • Patients with essential hypertension with an msSBP ≥ 140 mmHg and < 180 mmHg, and msDBP < 110 mmHg at Visits 2 and 3. (Visit 201 was deleted by the Administrative Changes document.)
  • Patients must have had a difference in msSBP of ≤ 20 mmHg between Visit 3 and the visit immediately prior to Visit 3.
  • Patients who were eligible and able to participate in the study, and who consented to do so after the purpose and nature of the investigation had been explained to them (written informed consent).

Exclusion Criteria:

  • History of renal artery stenosis.
  • Known Keith-Wagener grade III or IV hypertensive retinopathy.
  • History of hypertensive encephalopathy.
  • Current diagnosis of heart failure (New York Heart Association Class III-IV).
  • History of transient ischemic cerebral attack or cerebrovascular accident within 6 months.
  • History of myocardial infarction, bypass surgery, or any percutaneous coronary intervention within 6 months.
  • Current unstable angina pectoris. Patients on a stable dose of oral or topical nitrates or beta blockers for angina were acceptable.
  • Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia.
  • Clinically significant valvular heart disease.
  • Concurrent use of any antihypersensitive medications except a stable dose 3 months prior to visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., Flomax for BPH), beta blockers for angina, or beta blockers ophthalmic preparations.
Both
65 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00368277
CSPP100A2344
Not Provided
External Affairs, Novartis Pharmaceuticals
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
February 2011

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