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

• ClinicalTrials.gov Identifier: NCT01001572
• Recruitment Status: Completed
• First Posted: October 26, 2009
• Results First Posted: May 24, 2011
• Last Update Posted: May 24, 2011
• Sponsor: Novartis
• Information provided by: Novartis

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Essential Hypertension	Drug: Valsartan/amlodipine 160/5 mg; Drug: Valsartan 160 mg; Drug: Placebo	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 932 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Multi-national, Multi-center, Double-blind, Randomized, Parallel Study Comparing the Efficacy and Safety of Valsartan/Amlodipine 160/5 mg to Valsartan 160 mg Alone in Patients With Mild to Moderate Essential Hypertension Not Adequately Controlled With Valsartan 160 mg Monotherapy
• Study Start Date: September 2009
• Actual Primary Completion Date: May 2010
• Actual Study Completion Date: May 2010

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Valsartan 160 mg; 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; Valsartan 160 mg capsule taken orally once daily.; Other Name: Diovan® 160mg; Drug: Placebo; 1 capsule or tablet taken orally once daily
Experimental: Valsartan/amlodipine 160/5 mg; 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; Valsartan/amlodipine 160/5mg film coated tablets taken orally once daily.; Other Name: Exforge® 160/5mg; Drug: Placebo; 1 capsule or tablet taken orally once daily
Single-Blind Run-In Valsartan 160 mg; 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; Valsartan 160 mg capsule taken orally once daily.; Other Name: Diovan® 160mg

Outcome Measures

Primary Outcome Measures :

1. Change in Mean Sitting Diastolic Blood Pressure (MSDBP) From Baseline to Week 8 Endpoint [ Time Frame: Baseline and Week 8 ]
   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.

Secondary Outcome Measures :

1. Change in Mean Sitting Systolic Blood Pressure (MSSBP) From Baseline to Week 8 Endpoint [ Time Frame: Baseline and Week 8 ]
   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 MSSBP was calculated comparing the Week 8 readings to the readings taken at Baseline. The change from baseline in MSSBP was analyzed using an analysis of covariance model (ANCOVA) with treatment and center (pooled as appropriate) as factors and centered baseline MSSBP as a covariate
2. Percentage of Participants With a Diastolic Blood Pressure Response at 8 Week Endpoint [ Time Frame: Baseline and Week 8 ]
   The percentage of participants with a Diastolic Blood Pressure Response defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg or a >= 10 mmHg reduction from baseline.
3. Percentage of Participants With Diastolic Blood Pressure Control at 8 Week Endpoint [ Time Frame: Week 8 ]
   The percentage of participants with Diastolic Blood Pressure Control defined as the percentage of participants with a Mean Sitting Diastolic Blood Pressure (MSDBP) < 90 mmHg.
4. Percentage of Participants With Overall Blood Pressure Control at 8 Week Endpoint [ Time Frame: Week 8 ]
   The percentage of participants with Overall Blood Pressure Control defined as the percentage of participants with a Mean Sitting Systolic Blood Pressure (MSSBP)/Mean Sitting Diastolic Blood Pressure (MSDBP) < 140/90 mmHg.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Other protocol-defined inclusion/exclusion criteria may apply

Contacts and Locations

Sponsors and Collaborators

Novartis

Investigators

• Study Director: Novartis Pharmaceuticals; Sponsor GmbH

More Information

• Responsible Party: External Affairs, Novartis Pharmaceuticals
• ClinicalTrials.gov Identifier: NCT01001572
• Other Study ID Numbers: CVAA489A2317
• First Posted: October 26, 2009
• Results First Posted: May 24, 2011
• Last Update Posted: May 24, 2011
• Last Verified: May 2011

Keywords provided by Novartis:

Blood pressure; hypertension; Exforge; valsartan/amlodipine

Additional relevant MeSH terms:

Hypertension; Essential Hypertension; Vascular Diseases; Cardiovascular Diseases; Amlodipine; Valsartan; Antihypertensive Agents; Calcium Channel Blockers; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Calcium-Regulating Hormones and Agents; Physiological Effects of Drugs; Vasodilator Agents; Angiotensin II Type 1 Receptor Blockers; Angiotensin Receptor Antagonists