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

NCT00368277 | Completed Phase 3 Results

• 1 other identifier: CSPP100A2344
• Study Type: interventional
• Target: 901
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension

Keywords

Systolic hypertension; hypertension; aliskiren; blood pressure; ramipril; HTN

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Mean Sitting Systolic Blood Pressure to Week 12

  Baseline and Week 12

Secondary Outcomes (3)

• Percentage of Patients With Cough

  Weeks 12 and 36

• Percentage of Patients Achieving Blood Pressure Control at Weeks 12 and 36 Endpoints

  Weeks 12 and 36

• Change From Baseline in the Mean Sitting Diastolic Blood Pressure to Week 36

  Baseline and week 36

Study Arms (2)

Aliskiren-based regimen

EXPERIMENTAL

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; Drug: Hydrochlorothiazide; Drug: Amlodipine

Ramipril-based regimen

ACTIVE COMPARATOR

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; Drug: Hydrochlorothiazide; Drug: Amlodipine

Interventions

Aliskiren DRUG

Aliskiren 150 mg and 300 mg tablets taken orally, once a day in the morning

Aliskiren-based regimen

Ramipril DRUG

Ramipril 5 mg and 10 mg capsules taken orally, once a day in the morning

Ramipril-based regimen

Hydrochlorothiazide DRUG

Hydrochlorothiazide 12.5 or 25 mg capsules taken orally, once a day in the morning

Aliskiren-based regimen; Ramipril-based regimen

Amlodipine DRUG

Amlodipine 5 mg or 10 mg tablets taken orally, once a day in the morning

Aliskiren-based regimen; Ramipril-based regimen

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (1)

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Location

Related Publications (1)

• Wang GM, Li LJ, Tang WL, Wright JM. Renin inhibitors versus angiotensin converting enzyme (ACE) inhibitors for primary hypertension. Cochrane Database Syst Rev. 2020 Oct 22;10(10):CD012569. doi: 10.1002/14651858.CD012569.pub2.

  PMID: 33089502 DERIVED

MeSH Terms

Conditions

Hypertension; Isolated Systolic Hypertension

Interventions

aliskiren; Ramipril; Hydrochlorothiazide; Amlodipine

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Essential Hypertension

Intervention Hierarchy (Ancestors)

Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Chlorothiazide; Benzothiadiazines; Sulfonamides; Sulfones; Sulfur Compounds; Organic Chemicals; Thiazides; Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring

Results Point of Contact

• Title: Study Director
• Organization: Novaris Phamaceuticals

862-778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 22, 2006
• First Posted: August 24, 2006
• Study Start: September 1, 2006
• Primary Completion: February 1, 2008
• Study Completion: February 1, 2008
• Last Updated: March 25, 2011
• Results First Posted: March 25, 2011

Record last verified: 2011-02

Locations

US (1)