---
title: Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine
nct_id: NCT00367939
overall_status: COMPLETED
phase: PHASE3
sponsor: Novartis
study_type: INTERVENTIONAL
primary_condition: Hypertension
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00367939.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00367939"
ct_last_update_post_date: 2017-05-18
last_seen_at: "2026-05-12T07:13:44.485Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Efficacy and Safety of the Combination of Valsartan Plus Amlodipine in Hypertensive Patients Not Adequately Responding to the Combination Therapy With Ramipril Plus Felodipine

**Official Title:** An Multicenter Study to Evaluate the Efficacy and Safety of a 5 Week Therapy With the Combination of Valsartan 160 mg Plus Amlodipine 10 mg in Hypertensive Patients Not Adequately Responding to a 5 Week Therapy With Ramipril 5 mg and Felodipine 5 mg

**NCT ID:** [NCT00367939](https://clinicaltrials.gov/study/NCT00367939)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 132
- **Lead Sponsor:** Novartis
- **Conditions:** Hypertension
- **Start Date:** 2005-12
- **Completion Date:** 2006-07
- **CT.gov Last Update:** 2017-05-18

## Brief Summary

The purpose of this study is to evaluate the efficacy of valsartan plus amlodipine in hypertensive patients not responding to treatment with ACE inhibitor plus calcium channel blocker

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL

```
Inclusion Criteria:

* Male or female patients (18 years or older)
* Females must be either post-menopausal for one year, surgically sterile or using effective contraceptive methods (e.g. barrier method with spermicide, intra-uterine device, hormonal contraceptives).
* Patients with moderate essential hypertension (WHO II)

Exclusion Criteria:

* Severe hypertension
* Pregnant or nursing women
* Treated hypertensive patients with controlled hypertension under current therapy (MSDBP \< 90 mmHg and MSSBP \< 140 mmHg)
* A history of cardiovascular disease, including angina pectoris, myocardial infarction, coronary artery bypass graft, percutaneous transluminal coronary angioplasty, transient ischemic attack, stroke, and heart failure NYHA II - IV
* Other protocol-defined exclusion criteria may apply
```

## Interventions

- **valsartan + amlodipine** (DRUG)

## Primary Outcomes

- **To investigate whether 5 weeks of treatment with valsartan 160mg + amlodipine 10mg provide add'l mean sitting systolic BP reduction in patients not adequately responding to 5 weeks of treatment with ramipril + felodipine--i.e., mean systolic BP**

## Secondary Outcomes

- **To evaluate the effects of valsartan 160 mg plus amlodipine 10 mg on mean sitting diastolic BP, normalization and responder rate.**

## Locations (1)

- Investigative Centers, Germany

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.|investigative centers||germany` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT00367939.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT00367939*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*