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
  Purpose

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.


Condition Intervention Phase
Hypertension
Drug: Aliskiren
Drug: Ramipril
Drug: Hydrochlorothiazide
Drug: Amlodipine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 901
Study Start Date: September 2006
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Drug: Aliskiren
Aliskiren 150 mg and 300 mg tablets 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
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
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

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00368277

Locations
United States, New Jersey
Novartis Pharmaceuticals
East Hanover, New Jersey, United States, 07936
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00368277     History of Changes
Other Study ID Numbers: CSPP100A2344
Study First Received: August 22, 2006
Results First Received: December 14, 2010
Last Updated: February 28, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Novartis:
Systolic hypertension
hypertension
aliskiren
blood pressure
ramipril
HTN

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Hydrochlorothiazide
Amlodipine
Ramipril
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Diuretics
Natriuretic Agents
Physiological Effects of Drugs
Sodium Chloride Symporter Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Calcium Channel Blockers
Vasodilator Agents
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on August 26, 2014