Aliskiren Study of Safety and Efficacy in Senior Hypertensives

NCT01922141 | Withdrawn Phase 4 DMC

• 2 other identifiers: CSPP100A23702013-001562-42
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is designed to compare the blood pressure lowering efficacy of aliskiren, a combination of aliskiren plus amlodipine, and ramipril in elderly patients with mild to moderate hypertension. It will also compare the long-term safety of an aliskiren-based regimen to a ramipril-based regimen

Conditions

Hypertension

Keywords

High blood pressure, stage 1 and 2 hypertension

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mean sitting systolic blood pressure (MSSBP) to week 8

  The change from baseline to week 8 in mean sitting systolic blood pressure will be analyzed for aliskiren monotherapy, dual therapy of aliskiren and amlodipine and ramipril monotherapy using ANCOVA model in which treatment arm, region and age (less than 75 and greater than or equal to 75 years) will be included as factors

  Baseline, Week 8

Secondary Outcomes (6)

• Number of patients with serious adverse events and adverse events

  Baseline, Week 8, average 2.5 years

• Number of patients with hyperkalemia, hypotension and reduction of estimated glomerular filtration rate (eGFR)

  Baseline, Week 8

• Change from baseline in mean sitting systolic blood pressure (MSSBP) at the end of double blind period

  Baseline, end of double blind period (in average 2.5 years)

• Percentage of patients achieving blood pressure control

  Baseline, Week 8, average 2.5 years

• Percentage of patients with major cardiovascular events

  Average 2.5 years

Study Arms (3)

Aliskiren monotherapy

EXPERIMENTAL

Aliskiren 150 mg, once a day, force titrated to Aliskiren 300 mg after 8 weeks in 50% of patients. Optional addition/titration of amlodipine 5 mg/10 mg and hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps

Drug: Aliskiren; Drug: Amlodipine; Drug: Hydrochlorothiazide

Aliskiren dual therapy

EXPERIMENTAL

Aliskiren 150 mg plus amlodipine 5 mg, once a day, force titrated to Aliskiren 300 mg plus amlodipine 5 mg after 8 weeks in 50% of patients. Optional titration of amlodipine 5 mg to 10 mg and optional addition/titration of hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps

Drug: Aliskiren; Drug: Amlodipine; Drug: Hydrochlorothiazide

Ramipril monotherapy

ACTIVE COMPARATOR

Ramipril 5 mg, once a day, force titrated to Ramipril 10 mg after 8 weeks in 50% of patients. Optional addition/titration of amlodipine 5 mg/10 mg and hydrochlorothiazide 12.5/25 mg based on systolic BP control in sequential steps

Drug: Amlodipine; Drug: Ramipril; Drug: Hydrochlorothiazide

Interventions

Aliskiren DRUG

Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

Also known as: Rasilez, Tekturna

Aliskiren dual therapy; Aliskiren monotherapy

Amlodipine DRUG

Amlodipine 5 mg/10 mg will also be blinded and supplied centrally. For Aliskiren dual therapy arm , Amlodipine is in the regimen; where as for monotherapy arms, Amlodipine is an optional add-on therapy.

Aliskiren dual therapy; Aliskiren monotherapy; Ramipril monotherapy

Ramipril DRUG

Ramipril 5 mg and ramipril 10 mg capsules will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.

Ramipril monotherapy

Hydrochlorothiazide DRUG

Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.

Aliskiren dual therapy; Aliskiren monotherapy; Ramipril monotherapy

Eligibility Criteria

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

You may qualify if:

• Patients ≥ 65 years of age with a clinical diagnosis of essential hypertension at Visit 1.
• Mean sitting SBP (MSSBP) ≥ 140 mmHg and \< 180 mmHg at Visit 2/Visit 201 and Visit 3.
• Absolute MSSBP difference ≤ 20 mmHg between Visit 3 and the Visit immediately prior

You may not qualify if:

• History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes.
• Severe hypertension (MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg) at Visit 1, Visit 2, Visit 201 or Visit 3 or during patient self measured blood pressure (SMBP) monitoring in the pre-randomization period confirmed by office measurement.
• Current treatment with any blocker of the renin angiotensin aldosterone system (RAAS) (aliskiren, ACE inhibitor, angiotensin receptor blocker or an aldosterone antagonist) and unable to discontinue this therapy.
• Concurrent use of any anti-hypertensive medications except a stable dose of 3 months prior to Visit 1 of alpha adrenergic blockers for benign prostatic hypertrophy (e.g., tamsulosin \[Flomax®\] for benign prostatic hypertrophy), beta blockers for angina, or beta blocker ophthalmic preparations.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Hypertension

Interventions

aliskiren; Amlodipine; Ramipril; Hydrochlorothiazide

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2013
• First Posted: August 14, 2013
• Study Start: May 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: April 16, 2015

Record last verified: 2015-04