Efficacy/Safety of Valsartan Plus Amlodipine and Amlodipine Alone in Patients With Hypertension

NCT00413049 | Completed Phase 3 Results

• 1 other identifier: CVAA489A2315
• Study Type: interventional
• Target: 698
• Locations: 1 country
• Sites: 12

Brief Summary

This study will evaluate the safety and efficacy of the fixed combination of valsartan/amlodipine in adult patients with mild to moderate hypertension

Conditions

Hypertension

Keywords

Hypertension, valsartan, amlodipine, high blood pressure

Outcome Measures

Primary Outcomes (1)

• Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)

  Blood pressure (BP) was measured with a calibrated aneroid or mercury sphygmomanometer. The arm in which the highest sitting diastolic BP was found at study entry was used for all subsequent readings. At each visit, after the patient was in a sitting position for five minutes, systolic/diastolic BP was measured 3 times at 1-2-minute intervals. The mean of the 3 measurements was calculated. A negative change score indicates lowered BP.

  Baseline to end of study (Week 8)

Secondary Outcomes (5)

• Change in Mean Sitting Systolic Blood Pressure (msSBP) From Baseline to End of Study (Week 8)

  Baseline to end of study (Week 8)

• Percentage of Patients Achieving a Diastolic Response at the End of the Study (Week 8)

  Baseline to end of study (Week 8)

• Percentage of Patients Achieving Diastolic Control at the End of the Study (Week 8)

  Baseline to end of study (Week 8)

• Percentage of Patients Achieving Overall Control at the End of the Study (Week 8)

  Baseline to end of study (Week 8)

• Change in 24-hour Mean Ambulatory Diastolic and Systolic BP From Baseline at the End of the Study (Week 8)

  Baseline to end of study (Week 8)

Study Arms (2)

Valsartan/amlodipine 80/5 mg

EXPERIMENTAL

Drug: Valsartan/amlodipine 80/5 mg

Amlodipine 5 mg

ACTIVE COMPARATOR

Drug: Amlodipine 5 mg

Interventions

Valsartan/amlodipine 80/5 mg DRUG

1 valsartan/amlodipine 80/5 mg tablet and 1 placebo capsule matching amlodipine 5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Valsartan/amlodipine 80/5 mg

Amlodipine 5 mg DRUG

1 amlodipine 5 mg capsule and 1 placebo tablet matching valsartan/amlodipine 80/5 mg to be taken with water at approximately 8:00 a.m. once daily, except on the morning of every scheduled study visit, when study drug was taken after the completion of all other study procedures.

Amlodipine 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:

• Male or female outpatients ≥ 18 years and \< 86 years
• Patients with essential hypertension measured by calibrated mercury sphygmomanometer (preferred) or an aneroid device if a mercury sphygmomanometer was not available.
• At Visit 1, patients not treated with antihypertensive medications had to have a MSDBP of ≥ 95 mmHg and \< 110 mmHg; those patients treated with antihypertensive medication had to have a MSDBP of \< 110 mmHg.
• At Visit 2, patients must have a MSDBP of ≥ 95 mmHg but \< 110 mmHg.
• At Visit 3, patients must have a MSDBP of ≥ 90 mmHg and \< 110 mmHg.
• 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 clearly explained to them (written informed consent).

You may not qualify if:

• Severe hypertension (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 180 mmHg).
• In cases where the patient was on more than one antihypertensive drug whether in fixed or free combination, the investigator considered the efficacy and strength of each active ingredient in order to determine if the patient could be safely removed from their antihypertensive treatment.
• Known or suspected contraindications, including history of allergy or hypersensitivity to angiotensin receptor blockers (ARB), calcium channel blockers (CCB), or to drugs with similar chemical structures.
• Administration of any agent indicated for the treatment of hypertension after Visit 1 with the exception of those agents that required tapering down.
• Inability to discontinue all prior antihypertensive medications safely for a maximum period of up to 28 days prior to Visit 2, as required by the protocol.
• History of hypertensive encephalopathy, cerebrovascular accident or transient ischemic attack, myocardial infarction or all types of revascularization.
• Malignant hypertension.
• All patients with Type 1 diabetes mellitus and those patients with Type 2 diabetes mellitus who were not well controlled based on the investigator's clinical judgment. Patients being treated for diabetes mellitus had to have satisfactory metabolic control. Type 2 diabetic patients taking oral anti-diabetic medication had to be on a stable dose for at least 4 weeks prior to Visit 1.
• Pregnant or nursing (lactating) women, where pregnancy was defined as the state of a female after conception and until the termination of gestation, confirmed by a positive human chorionic gonadotropin (hCG) laboratory test (\> 5 mIU/ml).
• Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precluded intercourse with a male partner and women whose partners had been sterilized by vasectomy or other means, UNLESS they met the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum follicle stimulating hormone (FSH) levels \> 40 mIU/m or 6 weeks post-surgical bilateral oophorectomy with or without hysterectomy OR were using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), and double-barrier methods (any double combination of: intra-uterine device \[IUD\], male or female condom with spermicidal gel, diaphragm, sponge, cervical cap). Acceptable methods of contraception included total abstinence at the discretion of the investigator in cases where the age, career, lifestyle, or sexual orientation of the patient ensured compliance. Reliable contraception had to be maintained throughout the study and for 7 days after study drug discontinuation. Periodic abstinence (eg, calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal were not acceptable methods of contraception. Hormonal contraceptive use was disallowed.
• History of heart failure Grade II-IV according to the New York Heart Association (NYHA) classification.
• Second or third degree heart block with or without a pacemaker.
• Concomitant potentially life threatening arrhythmia or symptomatic arrhythmia.
• Angina pectoris of any type, including unstable angina pectoris.
• Clinically significant valvular heart disease.

Sponsors & Collaborators

• Novartis: lead

Study Sites (12)

China-Japan Friendship Hospital

Beijing, 100029, China

Location

People's hospital affiliated Beijing University

Beijing, 100044, China

Location

The third Xiangya hospital of central south University

Changsha, 410003, China

Location

The first hospital affiliated the third military Medical University

Chongqing, 400038, China

Location

The third hospital affiliated the third military Medical University

Chongqing, 400042, China

Location

Union hospital affiliated Fujian medical University

Fuzhou, 350001, China

Location

The first hospital affiliated Fujian medical University

Fuzhou, 350005, China

Location

The second hospital affiliated Jiangxi medical school

Nanchang, 330006, China

Location

Institute of Hypertension, Ruijin Hospital

Shanghai, 200025, China

Location

Zhongshan hospital affiliated Fudan University

Shanghai, 200032, China

Location

The sixth people's hospital of Shanghai

Shanghai, 200233, China

Location

The first hospital affiliated school of medical of Xi'an Jiaotong University

Xi'an, 710061, China

Location

Related Publications (1)

• Ke Y, Zhu D, Hong H, Zhu J, Wang R, Cardenas P, Zhang Y. Efficacy and safety of a single-pill combination of amlodipine/valsartan in Asian hypertensive patients inadequately controlled with amlodipine monotherapy. Curr Med Res Opin. 2010 Jul;26(7):1705-13. doi: 10.1185/03007995.2010.487391.

  PMID: 20469975 DERIVED

MeSH Terms

Conditions

Hypertension

Interventions

Valsartan; Amlodipine

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

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: December 18, 2006
• First Posted: December 19, 2006
• Study Start: January 1, 2007
• Primary Completion: November 1, 2007
• Study Completion: November 1, 2007
• Last Updated: April 29, 2011
• Results First Posted: February 8, 2011

Record last verified: 2011-04

Locations

CN (12)