Efficacy and Safety of Valsartan/Amlodipine in Patients With Mild to Moderate Essential Hypertension

NCT01001572 | Completed Phase 3 Results

• 1 other identifier: CVAA489A2317
• Study Type: interventional
• Target: 932
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study assessed the efficacy and safety of the valsartan/amlodipine 160/5 mg single-pill combination in patients with uncomplicated essential hypertension not adequately controlled (MSDBP ≥90 mmHg and \<110 mmHg) on valsartan 160 mg alone.

Conditions

Essential Hypertension

Keywords

Blood pressure; hypertension; Exforge; valsartan/amlodipine

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint

  Three arterial blood pressure (BP) determinations were made after the participant was in the sitting position for 5 minutes according to the American Heart Association guidelines using a calibrated standard aneroid or mercury sphygmomanometer or a calibrated standard sphygmomanometer. The change in the MSDBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSDBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSDBP as a covariate.

  Baseline and Week 8

Secondary Outcomes (4)

• Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint

  Baseline and Week 8

• Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint

  Baseline and Week 8

• Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint

  Week 8

• Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint

  Week 8

Study Arms (3)

Valsartan 160 mg

ACTIVE COMPARATOR

One capsule Valsartan 160 mg and 1 tablet placebo to Valsartan/Amlodipine taken orally once daily at approximately 9:00 AM for 8 weeks

Drug: Valsartan 160 mg; Drug: Placebo

Valsartan/amlodipine 160/5 mg

EXPERIMENTAL

One film-coated tablet Valsartan/amlodipine 160/5 mg and 1 capsule Placebo to Valsartan taken orally once daily at approximately 9:00 AM for 8 weeks

Drug: Valsartan/amlodipine 160/5 mg; Drug: Placebo

Single-Blind Run-In Valsartan 160 mg

OTHER

Single-Blind Run-In treatment with one capsule Valsartan 160 mg taken orally once daily at approximately 9:00 AM for 4 weeks.

Drug: Valsartan 160 mg

Interventions

Valsartan/amlodipine 160/5 mg DRUG

Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.

Also known as: Exforge® 160/5mg

Valsartan/amlodipine 160/5 mg

Valsartan 160 mg DRUG

Valsartan 160 mg capsule taken orally once daily.

Also known as: Diovan® 160mg

Single-Blind Run-In Valsartan 160 mg; Valsartan 160 mg

Placebo DRUG

1 capsule or tablet taken orally once daily

Valsartan 160 mg; Valsartan/amlodipine 160/5 mg

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must give written informed consent
• Male or female ages 18 or older and less than 86 years
• Diagnosed as having essential diastolic hypertension, as follows:
• Visit 2/Single-blind run-in entry, all participants MUST have a MSDBP ≥ 95 mmHg and \< 100 mmHg
• At Visit 3/Core double-blind treatment period entry, all patients MUST have a MSDBP \>=90 mmHg and \<110 mmHg

You may not qualify if:

• Severe hypertension
• Evidence of secondary form of hypertension (coarctation of the aorta, hyperaldosteronism, unilateral or bilateral renal artery stenosis, Cushing's disease, pheochromocytoma or polycystic kidney disease )
• Malignant hypertension
• Administration of any agent indicated for the treatment of hypertension after Visit 1
• Known moderate or malignant retinopathy.
• Known or suspected contraindications, including history of allergy or hypersensitivity to Angiotensin II Receptor Blockers (ARBs), Calcium Channel Blockers (CCBs), or to drugs with similar chemical structures
• History of hypertensive encephalopathy, cerebrovascular accident, or transient ischemic attack, myocardial infarction or all types of revascularization, angina pectoris of any type, including unstable angina
• History of heart failure Grade II-IV according to New York Heart Association (NYHA) classification
• Second of third degree heart block regardless of the use of a pacemaker, concomitant potentially life-threatening arrhythmia or symptomatic arrhythmia

Sponsors & Collaborators

• Novartis: lead

Study Sites (2)

Investigative site in Romainia

Location

Novartis Investigative Site

Location

MeSH Terms

Conditions

Essential Hypertension; Hypertension

Interventions

Valsartan; Amlodipine; Amlodipine, Valsartan Drug Combination

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential; Dihydropyridines; Pyridines; Drug Combinations; Pharmaceutical Preparations

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862 778-8300

Study Officials

• Novartis Pharmaceuticals

  Sponsor GmbH

  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: October 15, 2009
• First Posted: October 26, 2009
• Study Start: September 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: May 24, 2011
• Results First Posted: May 24, 2011

Record last verified: 2011-05