Aliskiren Study of Safety and Efficacy in Senior Hypertensives

Hypertension Clinical Trial

— ASSESS  

Official title:

A Randomized, Double-blind, Parallel Group, Active-controlled Study to Compare the Systolic Blood Pressure Lowering Efficacy of Aliskiren, Ramipril and a Combination of Aliskiren and Amlodipine, With an Initial 8-week Evaluation, Followed by a 2-3 Year Follow-up to Compare Long-term Safety of an Aliskiren-based Regimen to a Ramipril-based Regimen in Hypertensive Patients ≥ 65 Years of Age

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01922141
• Other study ID #: CSPP100A2370
• Secondary ID: 2013-001562-42
• Status: Withdrawn
• Phase: Phase 4
• First received: August 12, 2013
• Last updated: April 14, 2015
• Start date: May 2015
• Est. completion date: June 2018

Study information

• Verified date: April 2015
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: June 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

• Contraindications to aliskiren, ramipril, amlodipine, or hydrochlorothiazide. Other protocol defined inclusion/exclusion criteria apply

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypertension

Intervention

Drug:
• Aliskiren
Aliskiren 150 mg and aliskiren 300 mg tablets will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
• Amlodipine
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.
• Ramipril
Ramipril 5 mg and ramipril 10 mg capsules will be supplied centrally. These will be blinded with matching placebos for the 2 dose strengths.
• Hydrochlorothiazide
Hydrochlorothiazide 12.5 mg/25 mg will be open label and supplied locally. It is an optional add-on to each arm.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Pharmaceuticals

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of patients with serious adverse events and adverse events	Safety and tolerability of study treatments will be analyzed by comparing the frequency of serious adverse events and adverse events at the time frames	Baseline, Week 8, average 2.5 years	Yes
Secondary	Number of patients with hyperkalemia, hypotension and reduction of estimated glomerular filtration rate (eGFR)	The incidence of hyperkalemia, hypotension and reduction of eGFR will be compared between aliskiren monotherapy, aliskiren dual therapy with amlodipine and ramipril monotherapy	Baseline, Week 8	Yes
Secondary	Change from baseline in mean sitting systolic blood pressure (MSSBP) at the end of double blind period	Change in mean sitting systolic blood pressure will be analyzed for the aliskiren-based regimen vs. the ramipril based regimen	Baseline, end of double blind period (in average 2.5 years)	No
Secondary	Percentage of patients achieving blood pressure control	Percentage of patients achieving blood pressure control, defined as mean sitting systolic BP below 140 mmHg and mean sitting diastolic BP below 90 mmHg, will be analyzed for the study treatments	Baseline, Week 8, average 2.5 years	No
Secondary	Percentage of patients with major cardiovascular events	Percentage of patients with major cardiovascular events (defined as composite of cardiovascular death, resuscitated cardiac death, non-fatal stroke, non-fatal myocardial infarction, heart failure hospitalization and atrial fibrillation) will be analyzed for the aliskiren-based regimen and the ramipril-based regimen	Average 2.5 years	No
Secondary	Number of patients with gastrointestinal tract cancer	The frequency of gastrointestinal tract cancer (malignant neoplasms of mouth, esophagus, stomach, small intestine, appendix, anus, gastrointestinal stroma, colon and rectum, excluding pancreatic, biliary tract and liver cancers) will be analyzed for the aliskiren-based regimen and the ramipril-based regimen	Average 2.5 years	No